Intraoperative Fluid ManagementNCT06188299

Intraoperative Different Fluid Therapy Protocols

A study testing Restricted Fluid Administration in people with Intraoperative Fluid Management, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

We aimed to evaluate the relationship between different intraoperative fluid therapy protocols and postoperative renal damage and mortality. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Intraoperative Fluid Management
What is being tested?: Restricted Fluid Administration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 20 Jan 2022to 15 May 2023
Phase: Interventional
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Planned pancreatic surgery

Who cannot join

No exclusion criteria was presetted.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ankara Bilkent Şehir Hastanesi
Ankara, 06660

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects Of Intraoperative Different Fluid Therapy Protocols On Postoperative Renal Functions

We aimed to evaluate the relationship between different intraoperative fluid therapy protocols and postoperative renal damage and mortality.

Read the detailed description

Sixty patients who 18-65 age and underwent pancreatic surgery in our hospital were included in the study. They were divided into two groups as liberal fluid therapy (Group 1, n=30) and targeted fluid therapy (Group 2, n=30).

Conditions: Intraoperative Fluid Management
Being tested: Restricted Fluid Administration
Keywords: Liberal Fluid Therapy, Restrictive Fluid Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Restricted Fluid AdministrationOther
Restrictive fluid administration generally consists of partial or no replacement for the intravascular expansion from anesthesia, in which case vasopressors are usually administered, no replacement for the third space loss, and only partial replacement for deficits from preoperative fasting.

Study groups in NCT06188299
Study group	Role	What they receive
Liberal Group Therapy	No intervention	Liberal Fluid Therapy was administered to this group. Fluid restrictions were not used.
Targeted Fluid Therapy	Other	Targeted (restrictive) Fluid therapy was administered to this group. Fluids were given according to targeted blood pressure levels and aimed to avoid from fluid overload. Receives: Other: Restricted Fluid Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

AKI
Postoperative Renal Injury
Measured: 72 Hour
Mortality
Intraoperative and Postoperative Mortality Rate
Measured: 72 Hour

Secondary outcomes (1)

Blood Loss
Intraoperative total blood loss
Measured: Intraoperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 202215 May 2023

First posted3 Jan 2024
Study start20 Jan 2022
Primary completion1 Dec 2022
Study completion15 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Intraoperative Fluid ManagementStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Liberal Fluid Therapy Group and Targeted Fluid Therapy Groups.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06188299
Sponsor's protocol ID: E2-21-1078
Status last verified: Jul 2024
First submitted: 18 Dec 2023
Last updated: 17 Jul 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Messina A, Robba C, Calabro L, Zambelli D, Iannuzzi F, Molinari E, Scarano S, Battaglini D, Baggiani M, De Mattei G, Saderi L, Sotgiu G, Pelosi P, Cecconi M. Association between perioperative fluid administration and postoperative outcomes: a 20-year systematic review and a meta-analysis of randomized goal-directed trials in major visceral/noncardiac surgery. Crit Care. 2021 Feb 1;25(1):43. doi: 10.1186/s13054-021-03464-1.
PubMed 33522953
Oh TK, Song IA, Do SH, Jheon S, Lim C. Association of perioperative weight-based fluid balance with 30-day mortality and acute kidney injury among patients in the surgical intensive care unit. J Anesth. 2019 Jun;33(3):354-363. doi: 10.1007/s00540-019-02630-8. Epub 2019 Mar 27.
PubMed 30919134
Bihari S, Dixon DL, Painter T, Myles P, Bersten AD. Understanding Restrictive Versus Liberal Fluid Therapy for Major Abdominal Surgery Trial Results: Did Liberal Fluids Associate With Increased Endothelial Injury Markers? Crit Care Explor. 2021 Jan 25;3(1):e0316. doi: 10.1097/CCE.0000000000000316. eCollection 2021 Jan.
PubMed 33521643
Mason SA, Nathens AB, Finnerty CC, Gamelli RL, Gibran NS, Arnoldo BD, Tompkins RG, Herndon DN, Jeschke MG; Inflammation and the Host Response to Injury Collaborative Research Program.. Hold the Pendulum: Rates of Acute Kidney Injury are Increased in Patients Who Receive Resuscitation Volumes Less than Predicted by the Parkland Equation. Ann Surg. 2016 Dec;264(6):1142-1147. doi: 10.1097/SLA.0000000000001615.
PubMed 27828823
Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.
PubMed 20705785
Gottin L, Martini A, Menestrina N, Schweiger V, Malleo G, Donadello K, Polati E. Perioperative Fluid Administration in Pancreatic Surgery: a Comparison of Three Regimens. J Gastrointest Surg. 2020 Mar;24(3):569-577. doi: 10.1007/s11605-019-04166-4. Epub 2019 Apr 3.
PubMed 30945088
Yilmaz G, Akca A, Kiyak H, Can E, Aydin A, Salihoglu Z. Pleth Variability Index-Based Goal-Directed Fluid Management in Patients Undergoing Elective Gynecologic Surgery. Sisli Etfal Hastan Tip Bul. 2022 Jun 28;56(2):220-226. doi: 10.14744/SEMB.2021.81073. eCollection 2022.
PubMed 35990294
Collange O, Jazaerli L, Lejay A, Biermann C, Caillard S, Moulin B, Chakfe N, Severac F, Schaeffer M, Mertes PM, Steib A. Intraoperative Pleth Variability Index Is Linked to Delayed Graft Function After Kidney Transplantation. Transplant Proc. 2016 Oct;48(8):2615-2621. doi: 10.1016/j.transproceed.2016.06.046.
PubMed 27788791
Demirel I, Bolat E, Altun AY, Ozdemir M, Bestas A. Efficacy of Goal-Directed Fluid Therapy via Pleth Variability Index During Laparoscopic Roux-en-Y Gastric Bypass Surgery in Morbidly Obese Patients. Obes Surg. 2018 Feb;28(2):358-363. doi: 10.1007/s11695-017-2840-1.
PubMed 28762023
Fischer MO, Lemoine S, Tavernier B, Bouchakour CE, Colas V, Houard M, Greub W, Daccache G, Hulet C, Compere V, Taing D, Lorne E, Parienti JJ, Hanouz JL; Optimization using the Pleth Variability Index (OPVI) Trial Group. Individualized Fluid Management Using the Pleth Variability Index: A Randomized Clinical Trial. Anesthesiology. 2020 Jul;133(1):31-40. doi: 10.1097/ALN.0000000000003260.
PubMed 32205547

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 4
Phenotype Guided Vasoactive Medication During Kidney Transplantation
Kidney Transplant, Fluid Management
Recruiting
Goal-Directed Temperature Management During Prolonged Abdominal Surgery
Hypothermia Following Anesthesia, Intraoperative Complications
Recruiting
Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
Peritoneal Neoplasms, Hyperthermic Intraperitoneal Chemotherapy
Not yet recruiting
PRO STRESS Trial: Proactive Low-Dose Norepinephrine to Reduce Intraoperative Fluid Administration in Patients at High-Risk for Postoperative Pulmonary Complications Undergoing Laparoscopic Abdominal Surgery
Intraoperative Hypotension, Postoperative Pulmonary Complications (PPCs)
Recruiting
Restrictive Fluid Management In Liver Transplantation (REFIL)
Liver Transplantation (LT), End-stage Liver Disease (ESLD)

All Intraoperative Fluid Management trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects Of Intraoperative Different Fluid Therapy Protocols On Postoperative Renal Functions
ClinicalTrials.gov ID: NCT06188299
Acronym / sponsor ID: E2-21-1078
Conditions: Intraoperative Fluid Management
Keywords: Liberal Fluid Therapy, Restrictive Fluid Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Ankara City Hospital BilkentUniversity, hospital or other
Study start: 20 Jan 2022 (actual)
Primary completion: 1 Dec 2022 (actual)
Study completion: 15 May 2023 (actual)
First posted: 3 Jan 2024 (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.

We aimed to evaluate the relationship between different intraoperative fluid therapy protocols and postoperative renal damage and mortality.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Liberal Fluid Therapy Group and Targeted Fluid Therapy Groups.

Arm	Type	Receives
Liberal Group Therapy	No intervention	–Liberal Fluid Therapy was administered to this group. Fluid restrictions were not used.
Targeted Fluid Therapy	Other	Other: Restricted Fluid AdministrationTargeted (restrictive) Fluid therapy was administered to this group. Fluids were given according to targeted blood pressure levels and aimed to avoid from fluid overload.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Planned pancreatic surgery

Key exclusion criteria (1 listed)

No exclusion criteria was presetted.

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
Restricted Fluid AdministrationRestrictive fluid administration generally consists of partial or no replacement for the intravascular expansion from anesthesia, in which case vasopressors are usually administered, no replacement for the third space loss, and only partial replacement for deficits from preoperative fasting.	Other	Targeted Fluid Therapy

Primary outcome

AKI
Time frame: 72 Hour
Postoperative Renal Injury
Mortality
Time frame: 72 Hour
Intraoperative and Postoperative Mortality Rate

1 secondary outcome

Blood Loss
Time frame: Intraoperative period

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
Background: PubMed 33522953Messina A, Robba C, Calabro L, Zambelli D, Iannuzzi F, Molinari E, Scarano S, Battaglini D, Baggiani M, De Mattei G, Saderi L, Sotgiu G, Pelosi P, Cecconi M. Association between perioperative fluid administration and postoperative outcomes: a 20-year systematic review and a meta-analysis of randomized goal-directed trials in major visceral/noncardiac surgery. Crit Care. 2021 Feb 1;25(1):43. doi: 10.1186/s13054-021-03464-1.
Background: PubMed 30919134Oh TK, Song IA, Do SH, Jheon S, Lim C. Association of perioperative weight-based fluid balance with 30-day mortality and acute kidney injury among patients in the surgical intensive care unit. J Anesth. 2019 Jun;33(3):354-363. doi: 10.1007/s00540-019-02630-8. Epub 2019 Mar 27.
Background: PubMed 33521643Bihari S, Dixon DL, Painter T, Myles P, Bersten AD. Understanding Restrictive Versus Liberal Fluid Therapy for Major Abdominal Surgery Trial Results: Did Liberal Fluids Associate With Increased Endothelial Injury Markers? Crit Care Explor. 2021 Jan 25;3(1):e0316. doi: 10.1097/CCE.0000000000000316. eCollection 2021 Jan.
Background: PubMed 27828823Mason SA, Nathens AB, Finnerty CC, Gamelli RL, Gibran NS, Arnoldo BD, Tompkins RG, Herndon DN, Jeschke MG; Inflammation and the Host Response to Injury Collaborative Research Program.. Hold the Pendulum: Rates of Acute Kidney Injury are Increased in Patients Who Receive Resuscitation Volumes Less than Predicted by the Parkland Equation. Ann Surg. 2016 Dec;264(6):1142-1147. doi: 10.1097/SLA.0000000000001615.
Background: PubMed 20705785Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.
Background: PubMed 30945088Gottin L, Martini A, Menestrina N, Schweiger V, Malleo G, Donadello K, Polati E. Perioperative Fluid Administration in Pancreatic Surgery: a Comparison of Three Regimens. J Gastrointest Surg. 2020 Mar;24(3):569-577. doi: 10.1007/s11605-019-04166-4. Epub 2019 Apr 3.
Background: PubMed 35990294Yilmaz G, Akca A, Kiyak H, Can E, Aydin A, Salihoglu Z. Pleth Variability Index-Based Goal-Directed Fluid Management in Patients Undergoing Elective Gynecologic Surgery. Sisli Etfal Hastan Tip Bul. 2022 Jun 28;56(2):220-226. doi: 10.14744/SEMB.2021.81073. eCollection 2022.
Background: PubMed 27788791Collange O, Jazaerli L, Lejay A, Biermann C, Caillard S, Moulin B, Chakfe N, Severac F, Schaeffer M, Mertes PM, Steib A. Intraoperative Pleth Variability Index Is Linked to Delayed Graft Function After Kidney Transplantation. Transplant Proc. 2016 Oct;48(8):2615-2621. doi: 10.1016/j.transproceed.2016.06.046.
Background: PubMed 28762023Demirel I, Bolat E, Altun AY, Ozdemir M, Bestas A. Efficacy of Goal-Directed Fluid Therapy via Pleth Variability Index During Laparoscopic Roux-en-Y Gastric Bypass Surgery in Morbidly Obese Patients. Obes Surg. 2018 Feb;28(2):358-363. doi: 10.1007/s11695-017-2840-1.
Background: PubMed 32205547Fischer MO, Lemoine S, Tavernier B, Bouchakour CE, Colas V, Houard M, Greub W, Daccache G, Hulet C, Compere V, Taing D, Lorne E, Parienti JJ, Hanouz JL; Optimization using the Pleth Variability Index (OPVI) Trial Group. Individualized Fluid Management Using the Pleth Variability Index: A Randomized Clinical Trial. Anesthesiology. 2020 Jul;133(1):31-40. doi: 10.1097/ALN.0000000000003260.
Individual participant dataSharing planned: No

Related trials for Intraoperative Fluid Management

Enrolling by invitationPhase 4
Phenotype Guided Vasoactive Medication During Kidney Transplantation
Kidney Transplant, Fluid Management
Recruiting
Goal-Directed Temperature Management During Prolonged Abdominal Surgery
Hypothermia Following Anesthesia, Intraoperative Complications
Recruiting
Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
Peritoneal Neoplasms, Hyperthermic Intraperitoneal Chemotherapy
Not yet recruiting
PRO STRESS Trial: Proactive Low-Dose Norepinephrine to Reduce Intraoperative Fluid Administration in Patients at High-Risk for Postoperative Pulmonary Complications Undergoing Laparoscopic Abdominal Surgery
Intraoperative Hypotension, Postoperative Pulmonary Complications (PPCs)
Recruiting
Restrictive Fluid Management In Liver Transplantation (REFIL)
Liver Transplantation (LT), End-stage Liver Disease (ESLD)

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Restricted Fluid Administration in people with Intraoperative Fluid Management, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

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 1 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: finished, as of the sponsor's last update on 17 Jul 2024. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AKI (time frame: 72 Hour). The study lists 2 primary outcomes in all. 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 NCT06188299, which also lists 10 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 17 Jul 2024.