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

Fluid Overload Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339895
• Other study ID #: KOU KAEK 2015/99
• Status: Completed
• Phase: N/A
• First received: January 30, 2017
• Last updated: November 7, 2017
• Start date: January 1, 2016
• Est. completion date: January 25, 2017

Study information

• Verified date: November 2017
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 25, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• > 18 age

• elective colorectal suregry

• ASA 1-2

Exclusion Criteria:

• Chronic renal disease

• Ejection fraction < 30

• arthmia

Related Conditions & MeSH terms

• Fluid Overload

Intervention

Other:
• pvi-guided
pvi- guided total amount of crystalloid volume of fluid infused during colorectal surgery pvi-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
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FLUID MANAGEMENT	total fluid given during colorectal surgery	two hours