Clinical trial NCT02732301: Postoperative Gastrointestinal Dysfunction After Cardiac Surgery - Occurrence and Search for Biomarkers
Official title: Gastrointestinal Dysfunktion Efter hjärtkirurgi - förekomst Samt sökande Efter Nya biomarkörer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thoracic Surgical Procedures
Gastrointestinal Tract
Cardiopulmonary Bypass
Biomarkers
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Acute gastrointestinal injury score
timeFrame: Postoperative days 1-3
Secondary outcomes:
measure: Plasma protein expression
timeFrame: Postoperative days 1-3
measure: Gastrointestinal complications
timeFrame: 30 days postoperative
measure: All cause mortality
timeFrame: 30 days postoperative
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Department of Cardio-Thoracic and Vascular Surgery, Örebro University Hospital
Study officials:
affiliation: Department of Cardio-Thoracic and Vascular Surgery, Örebro University Hospital, Örebro, SWEDEN
name: Kristofer F Nilsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.