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

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.

Study Overview

• Status: Completed
• Conditions: Fluid Overload
• Intervention / Treatment: Other: pvı-guided; Other: traditional-guided

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Chronic renal disease
• Ejection fraction < 30
• arthmia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pvı-guided; pvı-guided(according to pvi value) fluid infused during whole procedure 2 ml/kg/h infusion during surgery	Other: pvı-guided; pvı- guided total amount of crystalloid volume of fluid infused during colorectal surgery pvı-guided(according to pvi value) fluid infused during whole procedure 2 ml/kg/h infusion during surgery If PVI value <%13 and if MAP>65mmHg continue with 2 ml/kg/h cristalloid infusion If PVI value <%13 and if MAP>65mmHg 5 mcg efedrin intravenous bolus till MAP>65 mmHg If PVI value >%13 and MAP>65 mmHg infuse 250 ml Gelofusine bolus up to PVI value lowers to %13 every 5 minute If PVI value >%13 and MAP <65 mmHg infuse 250 ml Gelofusine bolus and 5 mcg efedrin intravenous up to PVI value lowers to %13
Experimental: traditional-guided; 4-8 ml/kg/h infusion during surgery	Other: traditional-guided; traditional-guided total amount of crystalloid volume of fluid infused during colorectal surgery traditional-guided 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 Gelofusine bolus and 5 mcg efedrin If MAP>65 mmHg no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FLUID MANAGEMENT	total fluid given during colorectal surgery	two hours

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Principal Investigator: Sevim Cesur, MD, specialist; Study Director: Tülay Hoşten, MD, specialist

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 25, 2017

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 13, 2017
• Last Update Submitted That Met QC Criteria: November 7, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: COLORECTAL SURGERY; PVI GUIDED FLUID MANAGEMENT; GOAL DIRECTED THERAPY
• Other Study ID Numbers: KOU KAEK 2015/99

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No