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Measurement of Perioperative Glomerular Filtration Rate

Sponsor
University Hospital of North Norway (Other)
Overall Status
Completed
CT.gov ID
NCT03881332
Collaborator
(none)
4
Enrollment
1
Location
12.9
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Our objective is to monitor glomerular filtration rate (GFR)during the perioperative phase of patients undergoing robotic surgery for rectum or large bowel cancers. We will use both a single injection and a continuous infusion of iohexol to measure kidney function for 72 hours after surgery.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The considerable morbidity and mortality associated with perioperative acute kidney injury (AKI) is well documented and known to complicate recovery from surgery.

    Accurate, direct measurements of glomerular filtration rate (GFR) may provide a tool to monitor perioperative onset of rapidly changing renal function. This may subsequently lead to design of randomized controlled trials examining the effects of earlier intervention with the aim to reduce the incidence of perioperative AKI.

    Recently a protocol for continuous infusion of low-dose iohexol (CILDI) as a measure of GFR in stable patients over a range of GFR (28-128 mL/min/1.73 m2) has been developed. Accuracy of this infusion protocol was confirmed with the single bolus injection (SBI) method. Data also showed that the continuous infusion protocol of low-dose iohexol is an accurate and precise method when measuring changing GFR even in critical ill patients with variable AKI risks. Accordingly, SBI and CILDI together now allow us to explore unanswered research questions related to perioperative change in renal function.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    4 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Observational Study Using Iohexol to Measure Perioperative Glomerular Filtration Rate in Patients Undergoing Robotic Surgery for Rectum or Large Bowel Cancers
    Actual Study Start Date :
    Dec 26, 2019
    Actual Primary Completion Date :
    Jan 22, 2021
    Actual Study Completion Date :
    Jan 22, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Glomerular filtration rate [72 hours]

      Measured glomerular filtration rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Rectum or colon cancer
    Exclusion Criteria:
    • Acute kidney injury grade 3 or higher

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of North Norway Tromsø Troms Norway 9038

    Sponsors and Collaborators

    • University Hospital of North Norway

    Investigators

    • Study Chair: Lars Marius Ytrebo, PhD, University Hospital of North Norway

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lars Marius Ytrebo, Professor, University Hospital of North Norway
    ClinicalTrials.gov Identifier:
    NCT03881332
    Other Study ID Numbers:
    • 2018/1934
    First Posted:
    Mar 19, 2019
    Last Update Posted:
    Jan 26, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rectal Neoplasms
    Colonic Neoplasms

    Study Results

    No Results Posted as of Jan 26, 2021