Fluid OverloadNCT03956901
Goal Directed Fluid Management , Pvi
A study testing pvi guided fluid management in people with Fluid Overload, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The first objective of this study is to compare the liberal fluid management (LFM) with PVI guided goal-directed fluid management (GDFM) in gynecologic oncologic cases in terms of controlled intraoperative fluid balance, blood lactate levels, hemodynamic parameters, and postoperative serum creatinine levels. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Fluid Overload
- What is being tested?
- pvi guided fluid management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2019to 20 Jun 2020
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gynecological oncologic cases
- Patients over 18 years old
- ASA 1-2-3 patients
Who cannot join
- Patients with peripheral arterial disease
- Patients with non-sinus rhythm, arrhythmia, atrial fibrillation
- Patients with entry MAP <65 mmHg
- Patients with advanced renal and hepatic impairment
- Mental retarded and non-cooperative patients
- Patients with advanced heart failure, EF <30%
Show all 10Show fewer
- Patients have massive bleeding in the perioperative period, need for massive transfusion
- Patients have acute pulmonary pathology
- Patients with anaphylaxis who developed a blood product reaction
- Patients who do not allow a tidal volume of 8ml / kg in a mechanical ventilator
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Dr sadi konuk Education hospital
Istanbul
About this study
Official title: Peroperative and Postoperative Effects of Goal Directed Fluid Therapy in Gynecological Staging Surgery
The first objective of this study is to compare the liberal fluid management (LFM) with PVI guided goal-directed fluid management (GDFM) in gynecologic oncologic cases in terms of controlled intraoperative fluid balance, blood lactate levels, hemodynamic parameters, and postoperative serum creatinine levels. 112 patients who are in ASA I-II-lll risk groups included in this prospective study.
Read the detailed description
Objectives: The first objective of the investigators's study was to compare the liberal fluid management (LFM) with PVI guided goal-directed fluid management (GDFM) in terms of controlled intraoperative fluid volume, surgical end-point fluid balance, blood lactate and serum creatinine levels.
The investigators's secondary purpose was to compare the effects of different fluid regimens on the postoperative kidney injury and the duration of hospital stay.
Methods: The study included 112 American Society of Anesthesiologists (ASA) grade I ,ll and lll patients, aged above 18 and undergoing elective gynecologic oncologic case . After premedication with 0.03 mg /kg i.v. midazolam, all patients were started an i.v. infusion of 500 mL 0.9 % NaCl until the end of anesthesia induction.
After the anesthesia induction, while 0.9 % NaCl at rate of 2 mL/kg/h was infused in PVI- guided GDFM group, a 250-mL bolus cyristalloid/kolloid injection was administered when PVI was higher than 13 % over 5 min. While 0.9 % NaCl at rate of 4- 8 mL/kg/h was infused in LFM group, a 250-ml bolus cyristalloid/ kolloid injection was administered when the mean arterial blood pressure (MAP) decreased below 65 mmHg. In both groups, when MAP was still < 65 mmHg after fluid bolus infusion, 5 mg i.v. bolus ephedrine was administered. The data collected during intraoperative period, such as heart rate, MAP, arterial blood gas samples (Ph, arterial oxygen pressure (PaO2), arterial carbon dioxide pressure (PaCO2), HCO3 level, hemoglobin, blood lactate level) were recorded. Hemoglobin, Na, K, Cl, serum creatinine, blood lactate and serum albumin scores were measured preoperatively, and up to 24 hours postoperative.
In the first 24 hours after surgery, urine output, need for blood transfusion ,lokositoz,fever,stay in icu and length of hospital stay were recorded.
- Conditions
- Fluid Overload
- Being tested
- pvi guided fluid management
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pvi guided fluid managementOther
Also called liberal guided
GDFM Group: 500 ml bolus crystalloid after
2 ml \ kg crystalloid infusion to be started
If PVI <13 MAP is <65 mmHg, continue infusion of fluid, 1-2 µg NE bolus to be entered after 5 min.
PVI <13 MAP> 65 mmHg to continue fluid infusion If PVI> 13 MAP <65 mmHg, 250 ml bolus crystalloid \ colloid will be given and bolus 1-2 µg NE, If it continues after 5 minutes, liquid and NE doses will be repeated. Liquid treatment will be continued until PVI <13.
PVI> 13 MAP <65 mmHg 250 ml bolus fluid to be given, if continued 5 minutes later to be repeated,repetition of fluid will continue until PVl <13.
| Study group | Role | What they receive |
|---|---|---|
| Liberal Fluid Management | Experimental | liberal fluid management: 500 ml bolus crystalloid after 4-8 ml/kg/h infusion during surgery total amount of crystalloid volume of fluid infused during gycnecologcy l surgery fluid infused during whole procedure 4-8 ml/kg/h infusion during surgery If MAP <65 mmHg or <30%of basal value, infuse 250 ml cyristaloid/Gelofusine bolus and 5 mcg efedrin If MAP>65 mmHg no intervention Receives: Other: pvi guided fluid management |
| pvi guided fluid management | Experimental | GDFM Group: 500 ml bolus crystalloid after
2 ml \ kg crystalloid infusion to be started
If PVI <13 MAP is <65 mmHg, continue infusion of fluid, 1-2 µg NE bolus to be entered after 5 min.
PVI <13 MAP> 65 mmHg to continue fluid infusion If PVI> 13 MAP <65 mmHg, 250 ml bolus crystalloid \ colloid will be given and bolus 1-2 µg NE, If it continues after 5 minutes, liquid and NE doses will be repeated. Liquid treatment will be continued until PVI <13.
PVI> 13 MAP <65 mmHg 250 ml bolus fluid to be given, if continued 5 minutes later to be repeated,repetition of fluid will continue until PVl <13. Receives: Other: pvi guided fluid management |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid management
total fluid given durin operation
Measured: 3-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start8 Apr 2019
- Primary completion8 May 2019
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Güneş Özlem Yıldız, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- güneş özlem yildiz, Principal investigator, bakırköy Dr. Sadi Konuk Education hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956901
- Sponsor's protocol ID
- 2019/152
- Status last verified
- May 2020
- First submitted
- 17 May 2019
- Last updated
- 13 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peroperative and Postoperative Effects of Goal Directed Fluid Therapy in Gynecological Staging Surgery
- ClinicalTrials.gov ID
- NCT03956901
- Acronym / sponsor ID
- 2019/152
- Conditions
- Fluid Overload
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 8 May 2019 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 21 May 2019 (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.
The first objective of this study is to compare the liberal fluid management (LFM) with PVI guided goal-directed fluid management (GDFM) in gynecologic oncologic cases in terms of controlled intraoperative fluid balance, blood lactate levels, hemodynamic parameters, and postoperative serum creatinine levels. 112 patients who are in ASA I-II-lll risk groups included in this prospective study.
Detailed description
Objectives: The first objective of the investigators's study was to compare the liberal fluid management (LFM) with PVI guided goal-directed fluid management (GDFM) in terms of controlled intraoperative fluid volume, surgical end-point fluid balance, blood lactate and serum creatinine levels.
The investigators's secondary purpose was to compare the effects of different fluid regimens on the postoperative kidney injury and the duration of hospital stay.
Methods: The study included 112 American Society of Anesthesiologists (ASA) grade I ,ll and lll patients, aged above 18 and undergoing elective gynecologic oncologic case . After premedication with 0.03 mg /kg i.v. midazolam, all patients were started an i.v. infusion of 500 mL 0.9 % NaCl until the end of anesthesia induction.
After the anesthesia induction, while 0.9 % NaCl at rate of 2 mL/kg/h was infused in PVI- guided GDFM group, a 250-mL bolus cyristalloid/kolloid injection was administered when PVI was higher than 13 % over 5 min. While 0.9 % NaCl at rate of 4- 8 mL/kg/h was infused in LFM group, a 250-ml bolus cyristalloid/ kolloid injection was administered when the mean arterial blood pressure (MAP) decreased below 65 mmHg. In both groups, when MAP was still < 65 mmHg after fluid bolus infusion, 5 mg i.v. bolus ephedrine was administered. The data collected during intraoperative period, such as heart rate, MAP, arterial blood gas samples (Ph, arterial oxygen pressure (PaO2), arterial carbon dioxide pressure (PaCO2), HCO3 level, hemoglobin, blood lactate level) were recorded. Hemoglobin, Na, K, Cl, serum creatinine, blood lactate and serum albumin scores were measured preoperatively, and up to 24 hours postoperative.
In the first 24 hours after surgery, urine output, need for blood transfusion ,lokositoz,fever,stay in icu and length of hospital stay were recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal Fluid Management | Experimental | Other: pvi guided fluid managementliberal fluid management: 500 ml bolus crystalloid after 4-8 ml/kg/h infusion during surgery total amount of crystalloid volume of fluid infused during gycnecologcy l surgery fluid infused during whole procedure 4-8 ml/kg/h infusion during surgery If MAP <65 mmHg or <30%of basal value, infuse 250 ml cyristaloid/Gelofusine bolus and 5 mcg efedrin If MAP>65 mmHg no intervention |
| pvi guided fluid management | Experimental | Other: pvi guided fluid managementGDFM Group: 500 ml bolus crystalloid after 2 ml \ kg crystalloid infusion to be started If PVI <13 MAP is <65 mmHg, continue infusion of fluid, 1-2 µg NE bolus to be entered after 5 min. PVI <13 MAP> 65 mmHg to continue fluid infusion If PVI> 13 MAP <65 mmHg, 250 ml bolus crystalloid \ colloid will be given and bolus 1-2 µg NE, If it continues after 5 minutes, liquid and NE doses will be repeated. Liquid treatment will be continued until PVI <13. PVI> 13 MAP <65 mmHg 250 ml bolus fluid to be given, if continued 5 minutes later to be repeated,repetition of fluid will continue until PVl <13. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gynecological oncologic cases
- Patients over 18 years old
- ASA 1-2-3 patients
Key exclusion criteria (10 listed)
- Patients with peripheral arterial disease
- Patients with non-sinus rhythm, arrhythmia, atrial fibrillation
- Patients with entry MAP <65 mmHg
- Patients with advanced renal and hepatic impairment
- Mental retarded and non-cooperative patients
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 |
|---|---|---|
| pvi guided fluid managementAlso: liberal guidedGDFM Group: 500 ml bolus crystalloid after 2 ml \ kg crystalloid infusion to be started If PVI <13 MAP is <65 mmHg, continue infusion of fluid, 1-2 µg NE bolus to be entered after 5 min. PVI <13 MAP> 65 mmHg to continue fluid infusion If PVI> 13 MAP <65 mmHg, 250 ml bolus crystalloid \ colloid will be given and bolus 1-2 µg NE, If it continues after 5 minutes, liquid and NE doses will be repeated. Liquid treatment will be continued until PVI <13. PVI> 13 MAP <65 mmHg 250 ml bolus fluid to be given, if continued 5 minutes later to be repeated,repetition of fluid will continue until PVl <13. | Other | Liberal Fluid Management, pvi guided fluid management |
Primary outcome
fluid management
Time frame: 3-4 hours
total fluid given durin operation
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 13 Jul 2020.
Related trials for Fluid Overload
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
RecruitingObservational study
Using Bioimpedance Analysis to Monitor Fluid Status in Children
Fluid Overload
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Enrolling by invitationObservational study
Blood Volume Monitoring Via Critline in Volume Overload: Hospitalization and Readmission
End Stage Renal Disease (ESRD), Volume Overload
Not yet recruiting
Boston Medical Center Ultrasound Decongestion Study in Heart Failure
Congestive Heart Failure, Volume Overload
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.
güneş özlem yildiz principal investigator
bakırköy Dr. Sadi Konuk Education hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pvi guided fluid management in people with Fluid Overload, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital 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 3 inclusion and 10 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 13 Jul 2020. 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?
fluid management (time frame: 3-4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2020.