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

Cardiopulmonary Bypass Clinical Trial

— GAINDYSFUNCS  

Official title:

Gastrointestinal Dysfunktion Efter hjärtkirurgi - förekomst Samt sökande Efter Nya biomarkörer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02732301
• Other study ID #: 188051
• Status: Active, not recruiting
• Start date: November 2015
• Est. completion date: December 2022

Study information

• Verified date: March 2021
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 501
• Est. completion date: December 2022
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biomarkers
• Cardiopulmonary Bypass
• Gastrointestinal Tract
• Thoracic Surgical Procedures

Locations

Country	Name	City	State
Sweden	Department of Cardio-Thoracic and Vascular Surgery, Örebro University Hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Reintam Blaser A, Malbrain ML, Starkopf J, Fruhwald S, Jakob SM, De Waele J, Braun JP, Poeze M, Spies C. Gastrointestinal function in intensive care patients: terminology, definitions and management. Recommendations of the ESICM Working Group on Abdominal Problems. Intensive Care Med. 2012 Mar;38(3):384-94. doi: 10.1007/s00134-011-2459-y. Epub 2012 Feb 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute gastrointestinal injury score	Acute gastrointestinal injury score from Reintam Blaser et al (2012) modified for postoperative patients.	Postoperative days 1-3
Secondary	Plasma protein expression		Postoperative days 1-3
Secondary	Gastrointestinal complications		30 days postoperative
Secondary	All cause mortality		30 days postoperative