Comparison of PVI-guided Fluid Management With Traditional Fluid Management in Colorectal Surgery

Not Applicable

Completed

• Conditions: Fluid Overload
• Interventions: Other: traditional-guided; Other: pvı-guided

• Registration Number: NCT03339895
• Lead Sponsor: Kocaeli University

Brief Summary

The first objective of this study was to compare the traditional fluid management (TFM) 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. ASA I-II 70 patients included in this prospective study.

Detailed Description

Objectives: The first objective of our study was to compare the traditional fluid management (TFM) 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. Our secondary purpose was to compare the effects of different fluid regimens on the return of bowel function and the duration of hospital stay. Methods: The study included 70 American Society of Anesthesiologists (ASA) grade I and II patients, aged above 18 and undergoing elective colorectal surgery. 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 gelatin injection (Gelofusine®, Barun) 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 TFM group, a 250-ml bolus gelatin injection (Gelofusine®, Barun) 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, oliguria (\<0.5 ml / kg urine output), need for blood transfusion and the time of first bowel movement (depending on the days after surgery), length of hospital stay were recorded.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-25
• Study First Submitted: 2017-01-30
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-07
• Last Update Submitted: 2017-11-07
• Study First Posted: 2017-11-13
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• > 18 age
• elective colorectal suregry
• ASA 1-2

Exclusion Criteria

• Chronic renal disease
• Ejection fraction < 30
• arthmia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
traditional-guided	traditional-guided	4-8 ml/kg/h infusion during surgery
pvı-guided	pvı-guided	pvı-guided(according to pvi value) fluid infused during whole procedure 2 ml/kg/h infusion during surgery

Primary Outcome Measures

Name	Time	Method
FLUID MANAGEMENT	two hours	total fluid given during colorectal surgery