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

Primary Purpose

Laparoscopic Colorectal Surgery, Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pulse variability index
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Laparoscopic Colorectal Surgery focused on measuring NGAL, PVI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • laparoscopic surgery
  • obese patient

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    pulse variability index

    conventional fluid management

    Arm Description

    fluid management performed by pulse variability index

    fluid management performed by conventional fluid management

    Outcomes

    Primary Outcome Measures

    Diagnosis of acute kidney injury
    following up diagnosis of acute kidney injury

    Secondary Outcome Measures

    Full Information

    First Posted
    January 17, 2018
    Last Updated
    January 25, 2018
    Sponsor
    Ankara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03408834
    Brief Title
    The Effect of Fluid Management by Pleth Variability Index on Acute Kidney Injury in Obese Patients
    Official Title
    The Effect of Fluid Management by Pleth Variability Index on Acute Kidney Injury in Obese
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2, 2016 (Actual)
    Primary Completion Date
    September 2, 2017 (Actual)
    Study Completion Date
    October 2, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Laparoscopic Colorectal Surgery, Acute Kidney Injury
    Keywords
    NGAL, PVI

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pulse variability index
    Arm Type
    Active Comparator
    Arm Description
    fluid management performed by pulse variability index
    Arm Title
    conventional fluid management
    Arm Type
    Placebo Comparator
    Arm Description
    fluid management performed by conventional fluid management
    Intervention Type
    Other
    Intervention Name(s)
    pulse variability index
    Other Intervention Name(s)
    conventional
    Intervention Description
    fluid management with pulse variability index or conventional
    Primary Outcome Measure Information:
    Title
    Diagnosis of acute kidney injury
    Description
    following up diagnosis of acute kidney injury
    Time Frame
    postoperative 6 th hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: laparoscopic surgery obese patient Exclusion Criteria: patient refusal major comorbidity renal failure diabetes mellitus
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    CIGDEM YILDIRIMGUCLU
    Organizational Affiliation
    Ankara University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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