Clinical trial NCT03956901: Goal Directed Fluid Management , Pvi
Official title: Peroperative and Postoperative Effects of Goal Directed Fluid Therapy in Gynecological Staging Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Overload
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2019-05-21
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Gynecological oncologic cases
2. Patients over 18 years old
3. ASA 1-2-3 patients

Exclusion Criteria:

1. Patients with peripheral arterial disease
2. Patients with non-sinus rhythm, arrhythmia, atrial fibrillation
3. Patients with entry MAP \<65 mmHg
4. Patients with advanced renal and hepatic impairment
5. Mental retarded and non-cooperative patients
6. Patients with advanced heart failure, EF \<30%
7. Patients have massive bleeding in the perioperative period, need for massive transfusion
8. Patients have acute pulmonary pathology
9. Patients with anaphylaxis who developed a blood product reaction
10. Patients who do not allow a tidal volume of 8ml / kg in a mechanical ventilator

Primary outcomes:
measure: fluid management
timeFrame: 3-4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakırköy Dr sadi konuk Education hospital
Study officials:
affiliation: bakırköy Dr. Sadi Konuk Education hospital
name: güneş özlem yildiz
role: PRINCIPAL_INVESTIGATOR
References: