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

NCT ID: NCT03408834

Last Updated: 2018-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-02
• Study Completion Date: 2017-10-02

Brief Summary

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.

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.

Conditions

Laparoscopic Colorectal Surgery; Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

pulse variability index

fluid management performed by pulse variability index

Group Type: ACTIVE_COMPARATOR

pulse variability index

Intervention Type: OTHER

fluid management with pulse variability index or conventional

conventional fluid management

fluid management performed by conventional fluid management

Group Type: PLACEBO_COMPARATOR

pulse variability index

Intervention Type: OTHER

fluid management with pulse variability index or conventional

Interventions

pulse variability index

fluid management with pulse variability index or conventional

Intervention Type: OTHER

Other Intervention Names

conventional

Eligibility Criteria

Inclusion Criteria

• laparoscopic surgery
• obese patient

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

CIGDEM YILDIRIM GUCLU

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

CIGDEM YILDIRIMGUCLU

Role: STUDY_CHAIR

Ankara University

Other Identifiers

15-823-16

Identifier Type: -

Identifier Source: org_study_id