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

Gastrointestinal Dysfunktion Efter hjärtkirurgi - förekomst Samt sökande Efter Nya biomarkörer

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02732301

Acronym

GAINDYSFUNCS

Enrollment

501

Registered

2016-04-08

Start date

2015-11-30

Completion date

2022-12-31

Last updated

2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarkers, Cardiopulmonary Bypass, Gastrointestinal Tract, Thoracic Surgical Procedures

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Acute gastrointestinal injury score	Postoperative days 1-3	Acute gastrointestinal injury score from Reintam Blaser et al (2012) modified for postoperative patients.

Secondary

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

Countries

Sweden

Outcome results