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

NCT02732301 | Unknown

• 1 other identifier: 188051
• Study Type: observational
• Target: 501
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Acute gastrointestinal injury score

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

  Postoperative days 1-3

Secondary Outcomes (3)

• Plasma protein expression

  Postoperative days 1-3

• Gastrointestinal complications

  30 days postoperative

• All cause mortality

  30 days postoperative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing elective thoracic cardiovascular surgical procedures requiring intraoperative cardiopulmonary bypass at Örebro University Hospital, Örebro, Sweden, using a consecutive sampling method.

You may qualify if:

• Accepted for an elective thoracic cardiovascular surgical procedure requiring cardiopulmonary bypass
• \>18 years old

You may not qualify if:

• Present and severe symptoms from the gastrointestinal tract
• Previous major/extensive abdominal surgery
• Presence of astomy

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

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

Örebro, 70185, Sweden

Location

Related 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.

  PMID: 22310869 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Four plasma samples, 2 ml each, taken preoperatively and the three first postoperative days, which are stored in an approved biobank.

Study Officials

• Kristofer F Nilsson, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 8, 2016
• Study Start: November 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2022
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)