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GAINDYSFUNCS: Postoperative Gastrointestinal Dysfunction After Cardiac Surgery - Occurrence and Search for Biomarkers

Sponsor
Region Örebro County (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02732301
Collaborator
(none)
501
Enrollment
1
Location
85
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the frequency and grade of gastrointestinal dysfunction in patients after thoracic cardiovascular surgery, and to search for biomarkers of gastrointestinal dysfunction. All adult patients undergoing elective cardiac surgery requiring cardiopulmonary bypass at Örebro University Hospital, Örebro, Sweden, are asked for participation in this study. All participating patients sign informed consent at the inclusion. The first three postoperative days the function of the gastrointestinal tract is scored according to a rating scale (grade 0-4), along with other clinical parameters. Plasma blood samples are collected from each patient preoperatively and the first three postoperative days. The plasma samples are stored in a biobank for later determination of plasma proteins. In the analysis, the patients are divided according to the gastrointestinal rating scale and the plasma protein expression, gastrointestinal complications and all-cause mortality are compared between the groups.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    501 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Gastrointestinal Dysfunktion Efter hjärtkirurgi - förekomst Samt sökande Efter Nya biomarkörer
    Actual Study Start Date :
    Nov 1, 2015
    Actual Primary Completion Date :
    Oct 1, 2017
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Acute gastrointestinal injury score [Postoperative days 1-3]

      Acute gastrointestinal injury score from Reintam Blaser et al (2012) modified for postoperative patients.

    Secondary Outcome Measures

    1. Plasma protein expression [Postoperative days 1-3]

    2. Gastrointestinal complications [30 days postoperative]

    3. All cause mortality [30 days postoperative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Accepted for an elective thoracic cardiovascular surgical procedure requiring cardiopulmonary bypass

    • 18 years old

    Exclusion Criteria:

    • Present and severe symptoms from the gastrointestinal tract

    • Previous major/extensive abdominal surgery

    • Presence of astomy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Cardio-Thoracic and Vascular Surgery, Örebro University Hospital Örebro Sweden 70185

    Sponsors and Collaborators

    • Region Örebro County

    Investigators

    • Principal Investigator: Kristofer F Nilsson, MD, PhD, Department of Cardio-Thoracic and Vascular Surgery, Örebro University Hospital, Örebro, SWEDEN

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Region Örebro County
    ClinicalTrials.gov Identifier:
    NCT02732301
    Other Study ID Numbers:
    • 188051
    First Posted:
    Apr 8, 2016
    Last Update Posted:
    Mar 10, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 10, 2021