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

• Conditions: Thoracic Surgical Procedures; Gastrointestinal Tract; Biomarkers; Cardiopulmonary Bypass

• Registration Number: NCT02732301
• Lead Sponsor: Region Örebro County

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-04-04
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-08
• Primary Completion: 2017-10
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 501

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Gastrointestinal complications	30 days postoperative
Plasma protein expression	Postoperative days 1-3
All cause mortality	30 days postoperative

Trial Locations

Locations (1)

Department of Cardio-Thoracic and Vascular Surgery, Örebro University Hospital; 🇸🇪 Örebro, Sweden