The Effect of Fluid Management by Pleth Variability Index on Acute Kidney Injury in Obese Patients

The Effect of Fluid Management by Pleth Variability Index on Acute Kidney Injury in Obese

This study was to find out whether laparoscopic colorectal surgery is detrimental to the kidneys via PVI monitoring. To detect the kidney injury, so-called kidney troponin NGAL ,which gives earlier information than creatin in renal ischemic injury, was used.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Laparoscopic Colorectal Surgery
• Intervention / Treatment: Other: pulse variability index

Detailed Description

Our object in this study was to find out whether laparoscopic colorectal surgery is detrimental to the kidneys via PVI monitoring. To detect the kidney injury, so-called kidney troponin NGAL ,which gives earlier information than creatine in renal ischemic injury, was used.

Patients undergoing elective laparoscopic colorectal surgery, 18 to 75 years old, planned surgery duration longer than 2 hours, were included in this study. Patients were divided into 2 groups with respect to their fluid resuscitation, Group 1: goal directed fluid therapy via PVI monitoring Group 2: conventional fluid resuscitation. Blood samples were drawn from both groups for NGAL measurement before CO2 insufflation (T0), and at 6th(T1) and 12th(T2) hours after CO2 insufflation. At the end of the surgery, sugammadex was given to all patients for reversal of muscular blockade.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• laparoscopic surgery
• obese patient

Exclusion Criteria:

• patient refusal
• major comorbidity
• renal failure
• diabetes mellitus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: pulse variability index; fluid management performed by pulse variability index	Other: pulse variability index; fluid management with pulse variability index or conventional; Other Names: conventional
Placebo Comparator: conventional fluid management; fluid management performed by conventional fluid management	Other: pulse variability index; fluid management with pulse variability index or conventional; Other Names: conventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of acute kidney injury	following up diagnosis of acute kidney injury	postoperative 6 th hour

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Study Chair: CIGDEM YILDIRIMGUCLU, Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2016
• Primary Completion (Actual): September 2, 2017
• Study Completion (Actual): October 2, 2017

Study Registration Dates

• First Submitted: January 17, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: NGAL; PVI
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: 15-823-16

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