Thoracic Surgical ProceduresGAINDYSFUNCSNCT02732301
Postoperative Gastrointestinal Dysfunction After Cardiac Surgery - Occurrence and Search for Biomarkers
An observational study of Thoracic Surgical Procedures and Gastrointestinal Tract, run by Region Örebro County at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgical Procedures, Gastrointestinal Tract, Cardiopulmonary Bypass
- How many people
- 501 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2015to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Accepted for an elective thoracic cardiovascular surgical procedure requiring cardiopulmonary bypass
- >18 years old
Who cannot join
- Present and severe symptoms from the gastrointestinal tract
- Previous major/extensive abdominal surgery
- Presence of astomy
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Cardio-Thoracic and Vascular Surgery, Örebro University Hospital
Örebro, 70185
About this study
Official title: Gastrointestinal Dysfunktion Efter hjärtkirurgi - förekomst Samt sökande Efter Nya biomarkörer
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute gastrointestinal injury score
Acute gastrointestinal injury score from Reintam Blaser et al (2012) modified for postoperative patients.
Measured: Postoperative days 1-3
Secondary outcomes (3)
Plasma protein expression
Measured: Postoperative days 1-3
Gastrointestinal complications
Measured: 30 days postoperative
All cause mortality
Measured: 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionOct 2017
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristofer F Nilsson, MD, PhD, Principal investigator, Department of Cardio-Thoracic and Vascular Surgery, Örebro University Hospital, Örebro, SWEDEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732301
- Sponsor's protocol ID
- 188051
- Acronym
- GAINDYSFUNCS
- Status last verified
- Mar 2021
- First submitted
- 4 Apr 2016
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22310869
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Dysfunktion Efter hjärtkirurgi - förekomst Samt sökande Efter Nya biomarkörer
- ClinicalTrials.gov ID
- NCT02732301
- Acronym / sponsor ID
- GAINDYSFUNCS / 188051
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Accepted for an elective thoracic cardiovascular surgical procedure requiring cardiopulmonary bypass
- >18 years old
Key exclusion criteria (3 listed)
- Present and severe symptoms from the gastrointestinal tract
- Previous major/extensive abdominal surgery
- Presence of astomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute gastrointestinal injury score
Time frame: Postoperative days 1-3
Acute gastrointestinal injury score from Reintam Blaser et al (2012) modified for postoperative patients.
3 secondary outcomes
Plasma protein expression
Time frame: Postoperative days 1-3
Gastrointestinal complications
Time frame: 30 days postoperative
All cause mortality
Time frame: 30 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Background: PubMed 22310869Reintam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristofer F Nilsson, MD, PhD principal investigator
Department of Cardio-Thoracic and Vascular Surgery, Örebro University Hospital, Örebro, SWEDEN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgical Procedures and Gastrointestinal Tract, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute gastrointestinal injury score (time frame: Postoperative days 1-3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02732301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.