NCT03956901

Goal Directed Fluid Management , Pvi

Peroperative and Postoperative Effects of Goal Directed Fluid Therapy in Gynecological Staging Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Other Government
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fluid Overload

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-08
• Primary completion: 2019-05-08
• Completion: 2020-06-20
• First posted: 2019-05-21
• Last updated: 2020-07-13

Locations

1 site across 1 country: Turkey (Türkiye)