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

NCT ID: NCT02732301

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 501 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2022-12-31

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.

Conditions

Thoracic Surgical Procedures; Gastrointestinal Tract; Cardiopulmonary Bypass; Biomarkers

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristofer F Nilsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardio-Thoracic and Vascular Surgery, Örebro University Hospital, Örebro, SWEDEN

Locations

Department of Cardio-Thoracic and Vascular Surgery, Örebro University Hospital

Örebro, , Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 22310869 (View on PubMed)

Other Identifiers

188051

Identifier Type: -

Identifier Source: org_study_id