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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fluid Overload

Intervention / Treatment
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* Other: pvı-guided
* Other: traditional-guided


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 age elective colorectal suregry ASA 1-2 Exclusion Criteria: Chronic renal disease Ejection fraction < 30 arthmia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pvı-guided<br>pvı-guided(according to pvi value) fluid infused during whole procedure 2 ml/kg/h infusion during surgery | Other: pvı-guided<br>* 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<br>|
| Experimental: traditional-guided<br>4-8 ml/kg/h infusion during surgery | Other: traditional-guided<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COLORECTAL SURGERY, PVI GUIDED FLUID MANAGEMENT, GOAL DIRECTED THERAPY