Fluid TherapyFluid DayNCT03630744
Fluid Day Spanish Observational Study
An observational study of Fluid Therapy, run by Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor at 1 site in Spain.
Trial summary
Perioperative fluid therapy has undergone a huge change in clinical practice in recent years. The patterns of replacement and / or restoration of volemia described in the classic anaesthesiology books were supported by weak scientific evidence, and a paradigm shift in perioperative fluid therapy based on aspects such… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Fluid Therapy
- What is being tested?
- Fluid therapy
- How many people
- 3,500 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2019to Feb 2019
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population The fluid therapy administered by the anesthesiologists (Operating Room, PACU and resuscitation and critical units) will be recorded for all patients who are operated during the 24 hours of the study and who meet the inclusion criteria. The 24 hours of registration will be defined as the interval of 08:00 a.m. of the chosen day until 08:00 a.m. of the next day. Participation in this study only involves conducting an interview and collecting data from your clinical record referring to the 24 hours after your intervention, without making any additional intervention.
Who may be able to join
- Patients over 18 years of age surgically treated during the 24 hours of the two-day study of both scheduled and emergency surgery.
Who cannot join
- Interventions performed outside the surgical area: complementary examination cabinets.
- Interventions that do not require the presence of an anesthesiologist.
- Ophthalmologic surgery
- Surgery performed with local anesthesia.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Maria J Colomina, MD, PhD, 0034 629993697, mjcolomina@bellvithehospital.cat
Maria J Colomina, MD, PhD
About this study
Official title: Fluid Day: Observational Study About Fluid Therapy Administered in Adult Patients Undergoing Surgery in Our Country
Perioperative fluid therapy has undergone a huge change in clinical practice in recent years. The patterns of replacement and / or restoration of volemia described in the classic anaesthesiology books were supported by weak scientific evidence, and a paradigm shift in perioperative fluid therapy based on aspects such as increased mortality associated with an excessively positive balance of fluids in the perioperative period, evidences related to the non-existence of the third non-anatomical space and the need to preserve the capillary endothelium and its glycocalyx.
On the other hand, advances in technology, through the availability of less invasive monitoring systems, capable of determining dynamic parameters related to blood volume that allow predicting the response to volume management, have provided much more adequate monitoring and simple to guide such intravenous volume restoration.
Following all these changes different guidelines and recommendations have been published in recent years with the intention of clarifying the current evidence and facilitate the correct use of fluid therapy to clinicians, but despite this the fact is that today the investigators still do not have information on how fluid therapy is administered in daily practice, so the section of Hemostasis, Transfusion Medicine and Fluid Therapy of SEDAR, considered it necessary to evaluate the clinical practice of fluid therapy in the perioperative period through the Fluidday study.
Read the detailed description
Background: The administration of fluids in the perioperative period is a routine clinical practice that sometimes underestimates the repercussion of its correct administration.
According to the guidelines of the Spanish Society of Anesthesiology, Resuscitation and Therapy of Pain (SEDAR), the objective of perioperative fluid therapy is to maintain the organism with an optimal state of tissue perfusion and hydration.
This goal is not always easy to carry out. The continuous changes in surgical and anesthetic techniques and the appearance of new fluids and monitoring devices make it difficult for the anesthesiologist to carry out all these changes in his daily clinical practice. For this reason, SEDAR and other international scientific societies have recently published guidelines on the management of fluid therapy in the perioperative period, with the intention of facilitating the decision making of the anesthesiologist in their usual clinical practice based on current evidence. Also adding the recent withdrawal and commercial suspension of a special type of fluid such as Hydroxyethylstarch.
Hypothesis: Fluid therapy in the surgical environment is administered in a protocolized manner and in accordance with the recommendations of the different clinical practice guidelines.
Objectives: To evaluate the management of fluid therapy by anesthesiologists in adult patients during the perioperative period of scheduled and urgent surgery, taking into account the types of fluids administered, the monitoring used and the application of guided therapy protocols by objectives.
Methods: A multicenter prospective observational cross-sectional study - 24-hour Prevalence Cut off is proposed to evaluate the fluid therapy administered by anesthesiologists in surgical patients. The study will be carried out simultaneously in all hospitals that decide to participate throughout the Spanish territory and the follow-up period will be a maximum of 24 hours. Two different intersemanial days will be chosen to include the maximum number of episodes and types of surgeries.
Relevance: The clinical practice guidelines with their recommendations or suggestions offer a safety tool for patients based on current scientific evidence, hence the importance of its correct implementation. Sometimes problems of dissemination of information or limitations in the application of the same can cause that these objectives are not met.
From the Section of Hemostasis, Transfusion Medicine and Fluid Therapy of the SEDAR, it is intended to assess the implementation and follow-up of the recommendations and / or suggestions issued in the different clinical practice guidelines for the correct management of Fluid Therapy in the perioperative setting by performing of this study. This will allow locating the points of improvement in the usual clinical practice on perioperative fluid therapy and will contribute on the one hand to the implementation of the different clinical practice guidelines and, on the other hand, it will serve as a base material for the development of future lines of research.
- Conditions
- Fluid Therapy
- Being tested
- Fluid therapy
- Keywords
- fluid theraphy, surgical procedures, adult patients, glycocalyx, practice guideline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid therapyOther
- Analyze the type of fluid administered:
- crystalloids:
- Saline serum 0.9% ....... ml
- Ringer Lactate ........ ml
- Isofundin ® ........ ml
- Plasmalyte® ... ... ml
- Glucose Serum 5% ....... ml
- Glucose serum 10% ........ ml
- Glucosaline serum ........ ml
- colloids:
- Hydroxyethyl starch 130 / 0.4 ... ... ml
- Hydroxyethyl alimdon 130 / 0.42 ... .... ml
- Gelatins ... ....... ml
- Albumin 5% .......... ml
- Albumin 20% .......... ml.
- Analyze the total amount of crystalloids and liquid colloids administered in 24 hours in milliliters.
- Analyze the form of administration:
- Standard
- Standard with dosimeters
- on pump
| Study group | Role | What they receive |
|---|---|---|
| Adult patients undergoing surgery | Patients over 18 years surgically treated with fluid therapy during the 24 hours of the day study Receives: Other: Fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Management of fluid theraphy in the operating room and postoperative care.
The purpose of this study is to evaluate how fluids are administered in the Operating Room and postoperative care. We also collect data on the total amount of fluids administered and the type of fluid administered during the anesthesia procedure and surgery.
Type of Crystalloids and total amount in mL
- Saline serum 0.9% ....... ml
- Lactated Ringer ........ ml
- Isofundin ® ........ ml
- Plasmalyte® ... ... ml
- Glusose 5% ....... ml
- Glucose 10% ........ ml
- Saline \& Glucose 5% ........ ml Type of Colloids and total amount in mL
- HEA 130 / 0.4 ... ... ml
- HEA 130 / 0.42 ...... .... ml
- Gelatins ... ....... ml
- Albumin 5%.......... ml
- Albumin 20% ………..ml
Method of administration:
- Standard
- Standard with dosimeters
- In pump Use of goal-guided Fluid Therapy protocols
- YES
- NO
Use of Hemocomponents type and total does in mL:
- RBC..........mL
- Plasma..........................ml
- Platelets ..........ml
Measured: Two days
Secondary outcomes (5)
Monitorization
Type of monitors used in the operating room and postoperative care.
- Standard (NIBP, ECG, SpO2)
- Invasive Blood Pressure
- PVC
- Advanced hemodynamics: Specify: □ CAP □ TTP □ DTL □ TEE □ COP □ Other
- Dynamic Preload Parameters: Specify: □ VVS □ VPS □ VPP □ IVP
Targeted therapy protocol (Yes / No)
PANI: Non-invasive blood pressure ECG: Electrocardiogram SpO2: Partial oxygen saturation PVC: Central venous pressure CAP: Pulmonary artery catheter GC: Cardiac output TTP: Pulmonary thermodilution DTL: Transpulmonary Lithium Dilution ETT: Transesophageal echocardiography VVS: Systolic volume variation VPS: Systolic pressure variation VPP: Pulse pressure variation IVP: Index of plethysmographic variation
Measured: Two days
Demographic
Sex
- Female
- man Age……..years old Weight …….Kg Height ……..cms BMI ASA
Measured: Two days
Commorbidities
Renal Insufficiency
- Yes
- No Heart Failure
- Yes
- No Cardiac valve disease
- Yes
- no Pulmonary Hypertension
- Yes
- No Hepatopathy,
- Yes
- NO Arterial Hypertension,
- Yes
- NO Ischemic Heart Disease,
- Yes
- NO Dialysis
- Yes
- NO
Measured: Two days
Surgical procedure
Specialty and type of intervention. Duration of the surgical intervention. Postoperative follow-up time hours
Measured: Two days
Vasoactive support
Yes/Not, type quantity ml
Measured: Two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study startFeb 2019 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Fluid TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Hospital Universitario Infanta Leonor, Hospital Verge dels Lliris, Hospital Clinic of Barcelona, Hospital Universitario Doctor Peset, Hospital Miguel Servet, Hospital Universitario La Fe
- Responsible party
- Principal investigator, Maria José Clara Colomina Soler, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630744
- Sponsor's protocol ID
- HTF-FLU-2018-01
- Other IDs
- SED-HEA-2018-01
- Acronym
- Fluid Day
- Status last verified
- Aug 2018
- First submitted
- 30 Jun 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Approval of the study by the AEMPS and the CEIC of the Bellvitge University Hospital February - March 2018. Throughout this period of time, the promotion and inclusion of the different participating centers will be carried out. In addition to simultaneously performing the online database by the Statistics Department of the IDIBELL Foundation - Barcelona. Obtaining the approvals of the CEICS and relevant entities. It is expected that the days to make the cut can be done in February 2019. Subsequently, the statistical analysis will be carried out and the results will be presented at the Meeting of the Haemostasis, Transfusion Medicine and Fluid Therapy Section of the SEDAR in 2019 and the results will be sent to the journal that is deemed appropriate for publication.
Publications
Basora M, Colomina MJ, Moral V, Asuero de Lis MS, Boix E, Jover JL, Llau JV, Rodrigo MP, Ripolles J, Calvo Vecino JM. Clinical practice guide for the choice of perioperative volume-restoring fluid in adult patients undergoing non-cardiac surgery. Rev Esp Anestesiol Reanim. 2016 Jan;63(1):29-47. doi: 10.1016/j.redar.2015.06.013. Epub 2015 Sep 3. English, Spanish.
PubMed 26343809Colomina MJ, Basora M, Moral V, Llau JV. Crystalloids and hydroxyethyl starches in noncardiac surgical patients. Eur J Anaesthesiol. 2017 Jan;34(1):28-29. doi: 10.1097/EJA.0000000000000464. No abstract available.
PubMed 27136489Calvo-Vecino JM, Ripolles-Melchor J, Mythen MG, Casans-Frances R, Balik A, Artacho JP, Martinez-Hurtado E, Serrano Romero A, Fernandez Perez C, Asuero de Lis S; FEDORA Trial Investigators Group. Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial). Br J Anaesth. 2018 Apr;120(4):734-744. doi: 10.1016/j.bja.2017.12.018. Epub 2018 Feb 3.
PubMed 29576114Ripolles-Melchor J, Aldecoa C. Goal-directed Hemodynamic Therapy: Neither for Anyone, Neither the Same for Everyone. Anesthesiology. 2018 Mar;128(3):682-683. doi: 10.1097/ALN.0000000000002050. No abstract available.
PubMed 29438252Ripolles-Melchor J, Chappell D, Aya HD, Espinosa A, Mythen MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Erratum to: "Fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part III: Goal directed hemodynamic therapy. Rationale for maintaining vascular tone and contractility" [Rev Esp Anestesiol Reanim. 2017;64(6):348-359]. Rev Esp Anestesiol Reanim. 2017 Aug-Sep;64(7):425. doi: 10.1016/j.redar.2017.06.004. No abstract available. English, Spanish.
PubMed 28709478Ripolles-Melchor J, Chappell D, Aya HD, Espinosa A, Mythen MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Erratum to: "Fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part II: Goal directed hemodynamic therapy. Rationale for optimising intravascular volume" [Rev Esp Anestesiol Reanim. 2017;64(6):339-347]. Rev Esp Anestesiol Reanim. 2017 Aug-Sep;64(7):424. doi: 10.1016/j.redar.2017.06.003. No abstract available. English, Spanish.
PubMed 28709477Ripolles-Melchor J, Chappell D, Espinosa A, Mythen MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Erratum to: "Perioperative fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part I: Physiological background" [Rev Esp Anestesiol Reanim. 2017;64(6):328-338]. Rev Esp Anestesiol Reanim. 2017 Aug-Sep;64(7):423. doi: 10.1016/j.redar.2017.06.002. No abstract available. English, Spanish.
PubMed 28709476Ripolles-Melchor J, Chappell D, Espinosa A, Mhyten MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Perioperative fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part I: Physiological background. Rev Esp Anestesiol Reanim. 2017 Jun-Jul;64(6):328-338. doi: 10.1016/j.redar.2017.02.008. Epub 2017 Mar 30. No abstract available. English, Spanish.
PubMed 28364973Ripolles-Melchor J, Chappell D, Aya HD, Espinosa A, Mhyten MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part II: Goal directed hemodynamic therapy. Rationale for optimising intravascular volume. Rev Esp Anestesiol Reanim. 2017 Jun-Jul;64(6):339-347. doi: 10.1016/j.redar.2017.02.009. Epub 2017 Mar 24. No abstract available. English, Spanish.
PubMed 28343684Ripolles-Melchor J, Chappell D, Aya HD, Espinosa A, Mhyten MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part III: Goal directed hemodynamic therapy. Rationale for maintaining vascular tone and contractility. Rev Esp Anestesiol Reanim. 2017 Jun-Jul;64(6):348-359. doi: 10.1016/j.redar.2017.03.002. Epub 2017 Mar 24. No abstract available. English, Spanish.
PubMed 28343682Ripolles-Melchor J, Alvarez-Baena L, Espinosa A, Calvo-Vecino JM. Preoperative fluid loading in major abdominal surgery. Eur J Anaesthesiol. 2017 Jan;34(1):43-44. doi: 10.1097/EJA.0000000000000512. No abstract available.
PubMed 27898485Ripolles Melchor J, Fries D, Chappell D. Colloidophobia. Minerva Anestesiol. 2016 Oct;82(10):1039-1042. Epub 2016 Jun 28. No abstract available.
PubMed 27352071Ripolles-Melchor J, Casans-Frances R, Espinosa A, Abad-Gurumeta A, Feldheiser A, Lopez-Timoneda F, Calvo-Vecino JM; EAR Group, Evidence Anesthesia Review Group. Goal directed hemodynamic therapy based in esophageal Doppler flow parameters: A systematic review, meta-analysis and trial sequential analysis. Rev Esp Anestesiol Reanim. 2016 Aug-Sep;63(7):384-405. doi: 10.1016/j.redar.2015.07.009. Epub 2016 Feb 10. English, Spanish.
PubMed 26873025Ripolles-Melchor J, Espinosa A, Martinez-Hurtado E, Abad-Gurumeta A, Casans-Frances R, Fernandez-Perez C, Lopez-Timoneda F, Calvo-Vecino JM. Perioperative goal-directed hemodynamic therapy in noncardiac surgery: a systematic review and meta-analysis. J Clin Anesth. 2016 Feb;28:105-15. doi: 10.1016/j.jclinane.2015.08.004. Epub 2015 Oct 2.
PubMed 26440438Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11.
PubMed 26162676
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Day: Observational Study About Fluid Therapy Administered in Adult Patients Undergoing Surgery in Our Country
- ClinicalTrials.gov ID
- NCT03630744
- Acronym / sponsor ID
- Fluid Day / HTF-FLU-2018-01
- Conditions
- Fluid Therapy
- Keywords
- fluid theraphy, surgical procedures, adult patients, glycocalyx, practice guideline
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Sociedad Española de Anestesiología, Reanimación y Terapéutica del DolorUniversity, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Hospital Universitario Infanta Leonor, Hospital Verge dels Lliris, Hospital Clinic of Barcelona, Hospital Universitario Doctor Peset, Hospital Miguel Servet, Hospital Universitario La Fe
- Study start
- Feb 2019 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Perioperative fluid therapy has undergone a huge change in clinical practice in recent years. The patterns of replacement and / or restoration of volemia described in the classic anaesthesiology books were supported by weak scientific evidence, and a paradigm shift in perioperative fluid therapy based on aspects such as increased mortality associated with an excessively positive balance of fluids in the perioperative period, evidences related to the non-existence of the third non-anatomical space and the need to preserve the capillary endothelium and its glycocalyx.
On the other hand, advances in technology, through the availability of less invasive monitoring systems, capable of determining dynamic parameters related to blood volume that allow predicting the response to volume management, have provided much more adequate monitoring and simple to guide such intravenous volume restoration.
Following all these changes different guidelines and recommendations have been published in recent years with the intention of clarifying the current evidence and facilitate the correct use of fluid therapy to clinicians, but despite this the fact is that today the investigators still do not have information on how fluid therapy is administered in daily practice, so the section of Hemostasis, Transfusion Medicine and Fluid Therapy of SEDAR, considered it necessary to evaluate the clinical practice of fluid therapy in the perioperative period through the Fluidday study.
Detailed description
Background: The administration of fluids in the perioperative period is a routine clinical practice that sometimes underestimates the repercussion of its correct administration.
According to the guidelines of the Spanish Society of Anesthesiology, Resuscitation and Therapy of Pain (SEDAR), the objective of perioperative fluid therapy is to maintain the organism with an optimal state of tissue perfusion and hydration.
This goal is not always easy to carry out. The continuous changes in surgical and anesthetic techniques and the appearance of new fluids and monitoring devices make it difficult for the anesthesiologist to carry out all these changes in his daily clinical practice. For this reason, SEDAR and other international scientific societies have recently published guidelines on the management of fluid therapy in the perioperative period, with the intention of facilitating the decision making of the anesthesiologist in their usual clinical practice based on current evidence. Also adding the recent withdrawal and commercial suspension of a special type of fluid such as Hydroxyethylstarch.
Hypothesis: Fluid therapy in the surgical environment is administered in a protocolized manner and in accordance with the recommendations of the different clinical practice guidelines.
Objectives: To evaluate the management of fluid therapy by anesthesiologists in adult patients during the perioperative period of scheduled and urgent surgery, taking into account the types of fluids administered, the monitoring used and the application of guided therapy protocols by objectives.
Methods: A multicenter prospective observational cross-sectional study - 24-hour Prevalence Cut off is proposed to evaluate the fluid therapy administered by anesthesiologists in surgical patients. The study will be carried out simultaneously in all hospitals that decide to participate throughout the Spanish territory and the follow-up period will be a maximum of 24 hours. Two different intersemanial days will be chosen to include the maximum number of episodes and types of surgeries.
Relevance: The clinical practice guidelines with their recommendations or suggestions offer a safety tool for patients based on current scientific evidence, hence the importance of its correct implementation. Sometimes problems of dissemination of information or limitations in the application of the same can cause that these objectives are not met.
From the Section of Hemostasis, Transfusion Medicine and Fluid Therapy of the SEDAR, it is intended to assess the implementation and follow-up of the recommendations and / or suggestions issued in the different clinical practice guidelines for the correct management of Fluid Therapy in the perioperative setting by performing of this study. This will allow locating the points of improvement in the usual clinical practice on perioperative fluid therapy and will contribute on the one hand to the implementation of the different clinical practice guidelines and, on the other hand, it will serve as a base material for the development of future lines of research.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients undergoing surgery | – | Other: Fluid therapyPatients over 18 years surgically treated with fluid therapy during the 24 hours of the day study |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population The fluid therapy administered by the anesthesiologists (Operating Room, PACU and resuscitation and critical units) will be recorded for all patients who are operated during the 24 hours of the study and who meet the inclusion criteria. The 24 hours of registration will be defined as the interval of 08:00 a.m. of the chosen day until 08:00 a.m. of the next day. Participation in this study only involves conducting an interview and collecting data from your clinical record referring to the 24 hours after your intervention, without making any additional intervention.
Key inclusion criteria (1 listed)
- Patients over 18 years of age surgically treated during the 24 hours of the two-day study of both scheduled and emergency surgery.
Key exclusion criteria (4 listed)
- Interventions performed outside the surgical area: complementary examination cabinets.
- Interventions that do not require the presence of an anesthesiologist.
- Ophthalmologic surgery
- Surgery performed with local anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid therapy* Analyze the type of fluid administered: * crystalloids: * Saline serum 0.9% ....... ml * Ringer Lactate ........ ml * Isofundin ® ........ ml * Plasmalyte® ... ... ml * Glucose Serum 5% ....... ml * Glucose serum 10% ........ ml * Glucosaline serum ........ ml * colloids: * Hydroxyethyl starch 130 / 0.4 ... ... ml * Hydroxyethyl alimdon 130 / 0.42 ... .... ml * Gelatins ... ....... ml * Albumin 5% .......... ml * Albumin 20% .......... ml. * Analyze the total amount of crystalloids and liquid colloids administered in 24 hours in milliliters. * Analyze the form of administration: * Standard * Standard with dosimeters * on pump | Other | Adult patients undergoing surgery |
Primary outcome
Management of fluid theraphy in the operating room and postoperative care.
Time frame: Two days
The purpose of this study is to evaluate how fluids are administered in the Operating Room and postoperative care. We also collect data on the total amount of fluids administered and the type of fluid administered during the anesthesia procedure and surgery. Type of Crystalloids and total amount in mL * Saline serum 0.9% ....... ml * Lactated Ringer ........ ml * Isofundin ® ........ ml * Plasmalyte® ... ... ml * Glusose 5% ....... ml * Glucose 10% ........ ml * Saline \& Glucose 5% ........ ml Type of Colloids and total amount in mL * HEA 130 / 0.4 ... ... ml * HEA 130 / 0.42 ...... .... ml * Gelatins ... ....... ml * Albumin 5%.......... ml * Albumin 20% ………..ml Method of administration: * Standard * Standard with dosimeters * In pump Use of goal-guided Fluid Therapy protocols * YES * NO Use of Hemocomponents type and total does in mL: * RBC..........mL * Plasma..........................ml * Platelets ..........ml
5 secondary outcomes
Monitorization
Time frame: Two days
Demographic
Time frame: Two days
Commorbidities
Time frame: Two days
Surgical procedure
Time frame: Two days
Vasoactive support
Time frame: Two days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Background: PubMed 26343809Basora M, Colomina MJ, Moral V, Asuero de Lis MS, Boix E, Jover JL, Llau JV, Rodrigo MP, Ripolles J, Calvo Vecino JM. Clinical practice guide for the choice of perioperative volume-restoring fluid in adult patients undergoing non-cardiac surgery. Rev Esp Anestesiol Reanim. 2016 Jan;63(1):29-47. doi: 10.1016/j.redar.2015.06.013. Epub 2015 Sep 3. English, Spanish.
- Background: PubMed 27136489Colomina MJ, Basora M, Moral V, Llau JV. Crystalloids and hydroxyethyl starches in noncardiac surgical patients. Eur J Anaesthesiol. 2017 Jan;34(1):28-29. doi: 10.1097/EJA.0000000000000464. No abstract available.
- Background: PubMed 29576114Calvo-Vecino JM, Ripolles-Melchor J, Mythen MG, Casans-Frances R, Balik A, Artacho JP, Martinez-Hurtado E, Serrano Romero A, Fernandez Perez C, Asuero de Lis S; FEDORA Trial Investigators Group. Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial). Br J Anaesth. 2018 Apr;120(4):734-744. doi: 10.1016/j.bja.2017.12.018. Epub 2018 Feb 3.
- Background: PubMed 29438252Ripolles-Melchor J, Aldecoa C. Goal-directed Hemodynamic Therapy: Neither for Anyone, Neither the Same for Everyone. Anesthesiology. 2018 Mar;128(3):682-683. doi: 10.1097/ALN.0000000000002050. No abstract available.
- Background: PubMed 28709478Ripolles-Melchor J, Chappell D, Aya HD, Espinosa A, Mythen MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Erratum to: "Fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part III: Goal directed hemodynamic therapy. Rationale for maintaining vascular tone and contractility" [Rev Esp Anestesiol Reanim. 2017;64(6):348-359]. Rev Esp Anestesiol Reanim. 2017 Aug-Sep;64(7):425. doi: 10.1016/j.redar.2017.06.004. No abstract available. English, Spanish.
- Background: PubMed 28709477Ripolles-Melchor J, Chappell D, Aya HD, Espinosa A, Mythen MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Erratum to: "Fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part II: Goal directed hemodynamic therapy. Rationale for optimising intravascular volume" [Rev Esp Anestesiol Reanim. 2017;64(6):339-347]. Rev Esp Anestesiol Reanim. 2017 Aug-Sep;64(7):424. doi: 10.1016/j.redar.2017.06.003. No abstract available. English, Spanish.
- Background: PubMed 28709476Ripolles-Melchor J, Chappell D, Espinosa A, Mythen MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Erratum to: "Perioperative fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part I: Physiological background" [Rev Esp Anestesiol Reanim. 2017;64(6):328-338]. Rev Esp Anestesiol Reanim. 2017 Aug-Sep;64(7):423. doi: 10.1016/j.redar.2017.06.002. No abstract available. English, Spanish.
- Background: PubMed 28364973Ripolles-Melchor J, Chappell D, Espinosa A, Mhyten MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Perioperative fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part I: Physiological background. Rev Esp Anestesiol Reanim. 2017 Jun-Jul;64(6):328-338. doi: 10.1016/j.redar.2017.02.008. Epub 2017 Mar 30. No abstract available. English, Spanish.
- Background: PubMed 28343684Ripolles-Melchor J, Chappell D, Aya HD, Espinosa A, Mhyten MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part II: Goal directed hemodynamic therapy. Rationale for optimising intravascular volume. Rev Esp Anestesiol Reanim. 2017 Jun-Jul;64(6):339-347. doi: 10.1016/j.redar.2017.02.009. Epub 2017 Mar 24. No abstract available. English, Spanish.
- Background: PubMed 28343682Ripolles-Melchor J, Chappell D, Aya HD, Espinosa A, Mhyten MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part III: Goal directed hemodynamic therapy. Rationale for maintaining vascular tone and contractility. Rev Esp Anestesiol Reanim. 2017 Jun-Jul;64(6):348-359. doi: 10.1016/j.redar.2017.03.002. Epub 2017 Mar 24. No abstract available. English, Spanish.
- Background: PubMed 27898485Ripolles-Melchor J, Alvarez-Baena L, Espinosa A, Calvo-Vecino JM. Preoperative fluid loading in major abdominal surgery. Eur J Anaesthesiol. 2017 Jan;34(1):43-44. doi: 10.1097/EJA.0000000000000512. No abstract available.
- Background: PubMed 27352071Ripolles Melchor J, Fries D, Chappell D. Colloidophobia. Minerva Anestesiol. 2016 Oct;82(10):1039-1042. Epub 2016 Jun 28. No abstract available.
- Individual participant dataSharing planned: Yes. Approval of the study by the AEMPS and the CEIC of the Bellvitge University Hospital February - March 2018. Throughout this period of time, the promotion and inclusion of the different participating centers will be carried out. In addition to simultaneously performing the online database by the Statistics Department of the IDIBELL Foundation - Barcelona. Obtaining the approvals of the CEICS and relevant entities. It is expected that the days to make the cut can be done in February 2019. Subsequently, the statistical analysis will be carried out and the results will be presented at the Meeting of the Haemostasis, Transfusion Medicine and Fluid Therapy Section of the SEDAR in 2019 and the results will be sent to the journal that is deemed appropriate for publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hospital Universitario Bellvitge
L'Hospitalet de Llobregat, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Therapy, run by Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Management of fluid theraphy in the operating room and postoperative care. (time frame: Two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03630744, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.