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

NCT ID: NCT03339895

Last Updated: 2017-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2017-01-25

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.

Conditions

Fluid Overload

Keywords

COLORECTAL SURGERY; PVI GUIDED FLUID MANAGEMENT; GOAL DIRECTED THERAPY

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

pvı-guided

pvı-guided(according to pvi value) fluid infused during whole procedure 2 ml/kg/h infusion during surgery

Group Type: EXPERIMENTAL

pvı-guided

Intervention Type: OTHER

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

traditional-guided

4-8 ml/kg/h infusion during surgery

Group Type: EXPERIMENTAL

traditional-guided

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Chronic renal disease
• Ejection fraction < 30
• arthmia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Sevim Cesur

DR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sevim Cesur, MD

Role: PRINCIPAL_INVESTIGATOR

Specialist

Tülay Hoşten, MD

Role: STUDY_DIRECTOR

Specialist

Other Identifiers

KOU KAEK 2015/99

Identifier Type: -

Identifier Source: org_study_id