Goal Directed Fluid Management , Pvi
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| ClinicalTrials.gov Identifier: NCT03956901 |
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Recruitment Status :
Recruiting
First Posted : May 21, 2019
Last Update Posted : May 29, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fluid Overload | Other: pvi guided fluid management | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 112 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Other |
| Official Title: | Peroperative and Postoperative Effects of Goal Directed Fluid Therapy in Gynecological Staging Surgery |
| Actual Study Start Date : | April 8, 2019 |
| Estimated Primary Completion Date : | September 8, 2019 |
| Estimated Study Completion Date : | December 30, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Liberal Fluid Management
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
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Other: pvi guided fluid management
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. Other Name: liberal guided |
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Experimental: pvi guided fluid management
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. |
Other: pvi guided fluid management
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. Other Name: liberal guided |
- fluid management [ Time Frame: 3-4 hours ]total fluid given durin operation
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Gynecological oncologic cases
- Patients over 18 years old
- ASA 1-2-3 patients
Exclusion Criteria:
- 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%
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956901
| Contact: gunes ozlem MD yildiz, specialist | +905303603749 | drgunesim@hotmail.com | |
| Contact: duygu md akyol, specialist | 05447616034 | duygu.aygun@saglik.gov.tr |
| Turkey | |
| Bakırköy Dr sadi konuk Education hospital | Recruiting |
| Istanbul, Turkey | |
| Contact: güneş özlem yildiz 905303603749 drgunesim@hotmail.com | |
| Principal Investigator: | güneş özlem yildiz | bakırköy Dr. Sadi Konuk Education hospital |
| Responsible Party: | Güneş Özlem Yıldız, principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital |
| ClinicalTrials.gov Identifier: | NCT03956901 |
| Other Study ID Numbers: |
2019/152 |
| First Posted: | May 21, 2019 Key Record Dates |
| Last Update Posted: | May 29, 2019 |
| Last Verified: | May 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |