Gastrointestinal DysfunctionNCT04979494
Association Between SMA Flow and AGI in Critically Ill Patients
An observational study of Gastrointestinal Dysfunction and Critical Illness, run by Xinchen Wang at 1 site in China.
Trial summary
Acute gastrointestinal injury (AGI) is related to poor outcomes of critically ill patients [1] through many underlying mechanisms [2]. It is also a part of the process of multiple organ dysfunction syndrome (MODS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Dysfunction, Critical Illness
- What is being tested?
- ultrasound examination
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 30 Sep 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted into the Department of Critical Care Medicine of Peking Union Medical College Hospital, who were eligible of inclusion criteria, were included in the study.
Who may be able to join
- 18 ~ 80 years old;
- Under deep sedation (RASS score ≤ -3) with mechanical ventilation at the time of enrollment;
- Acute Physiology and Chronic Health Evaluation II (APACHE-II) score ≥8.
Who cannot join
- Pregnancy;
- Recent gastrointestinal surgery;
- History of acute or chronic gastrointestinal dysfunction before ICU admission;
- Primary or secondary vascular malformation of SMA;
- Any contraindication to the use of ultrasound evaluation (e.g., abdominal incision).
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Science
Beijing
About this study
Official title: Association Between Blood Flow of Super Mesenteric Artery (SMA) and Acute Gastrointestinal Injury (AGI) Using Point-of-care Ultrasound in Critical Care Unit
Acute gastrointestinal injury (AGI) is related to poor outcomes of critically ill patients [1] through many underlying mechanisms [2]. It is also a part of the process of multiple organ dysfunction syndrome (MODS). However, the morbidity of acute gastrointestinal dysfunction in critically ill patients is highly underestimated due to the scarcity of accurate measurement and thus the causes are still unclear.
In this study, investigators are going to apply the technique of point-of-care ultrasound (POCUS) evaluation on the bowel diameters, wall thickness and movement combined with intra-abdominal pressure to determine the occurrence of AGI. The superior mesenteric artery (SMA) blood flow is also evaluated by POCUS to find out the association between SMA blood flow and AGI.
Read the detailed description
- Patients are recruited within 24 hours of our surgical ICU admission. The patients are mostly admitted for post-surgery monitor in case of complications due to their baseline health conditions. In some cases, patients are admitted from the emergency room because of severe sickness. Those who are with deep sedation and mechanical ventilation during the first ultrasound evaluation are eligible for the study.
- Written informed consent was obtained from all patients or next of kin before the recruitment.
- Information will be collected at enrollment, including demographic characteristics, diagnosis, and so on.
- There will be two phases of ultrasound evaluation. In Phase One, investigators perform ultrasound evaluation within 24 hours after ICU admission to investigate the SMA blood flow in supine position using POCUS. In Phase Two, starting after the enteral feeding has been initiated, usually within 3 days after the enrollment, ultrasound evaluation on GI function will be performed according to gastrointestinal and urinary tract sonography ultrasound (GUTS) protocol using POCUS. GUTS protocol includes the ultrasound measurement for bowel diameter, bowel wall thickness, peristalsis combined with intra-abdominal pressure(IAP) measured through ureteral catheterization. All measurements would be used to calculate GUTS score to grade the AGI [4].
- Conditions
- Gastrointestinal Dysfunction, Critical Illness
- Being tested
- ultrasound examination
- Keywords
- Regional blood flow, Gastrointestinal dysfunction, Critical care
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound examinationOther
We conduct abdominal ultrasound examinations for each patient.
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurence of acute gastrointestinal injury
Gastrointestinal and urinary tract sonography ultrasound (GUTS) score will be calculate using a combination bowel diameter in centimeters, bowel wall thickness in centimeters, peristalsis (with or without) using ultrasound, and intra-abdominal pressure in millimeters of mercury measured through urethral tubes[3]. GUTS score is ranging from 0 to 4, and a higher GUTS score means worse gastrointestinal function. A GUTS score more than or equal to 2 is considered as acute gastrointestinal injury(AGI)in this study.
Measured: Within 24 hours after the initiation of enteral feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Sep 2020
- Primary completion1 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DysfunctionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinchen Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xinchen Wang, Peking Union Medical College Hospital
- Investigators
- Dawei Liu, MSc., Study chair, Peking Union Medical College Hospital, Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979494
- Sponsor's protocol ID
- PUMCH-JS-2687
- Status last verified
- Aug 2024
- First submitted
- 4 May 2021
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reintam Blaser A, Poeze M, Malbrain ML, Bjorck M, Oudemans-van Straaten HM, Starkopf J; Gastro-Intestinal Failure Trial Group. Gastrointestinal symptoms during the first week of intensive care are associated with poor outcome: a prospective multicentre study. Intensive Care Med. 2013 May;39(5):899-909. doi: 10.1007/s00134-013-2831-1. Epub 2013 Jan 31.
PubMed 23370829Meng M, Klingensmith NJ, Coopersmith CM. New insights into the gut as the driver of critical illness and organ failure. Curr Opin Crit Care. 2017 Apr;23(2):143-148. doi: 10.1097/MCC.0000000000000386.
PubMed 28092310Perko MJ, Madsen P, Perko G, Schroeder TV, Secher NH. Mesenteric artery response to head-up tilt-induced central hypovolaemia and hypotension. Clin Physiol. 1997 Sep;17(5):487-96. doi: 10.1046/j.1365-2281.1997.05252.x.
PubMed 9347197Gao T, Cheng MH, Xi FC, Chen Y, Cao C, Su T, Li WQ, Yu WK. Predictive value of transabdominal intestinal sonography in critically ill patients: a prospective observational study. Crit Care. 2019 Nov 27;23(1):378. doi: 10.1186/s13054-019-2645-9.
PubMed 31775838
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Blood Flow of Super Mesenteric Artery (SMA) and Acute Gastrointestinal Injury (AGI) Using Point-of-care Ultrasound in Critical Care Unit
- ClinicalTrials.gov ID
- NCT04979494
- Acronym / sponsor ID
- PUMCH-JS-2687
- Conditions
- Gastrointestinal Dysfunction, Critical Illness
- Keywords
- Regional blood flow, Gastrointestinal dysfunction, Critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Xinchen WangUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 28 Jul 2021 (actual)
- 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.
Acute gastrointestinal injury (AGI) is related to poor outcomes of critically ill patients [1] through many underlying mechanisms [2]. It is also a part of the process of multiple organ dysfunction syndrome (MODS). However, the morbidity of acute gastrointestinal dysfunction in critically ill patients is highly underestimated due to the scarcity of accurate measurement and thus the causes are still unclear.
In this study, investigators are going to apply the technique of point-of-care ultrasound (POCUS) evaluation on the bowel diameters, wall thickness and movement combined with intra-abdominal pressure to determine the occurrence of AGI. The superior mesenteric artery (SMA) blood flow is also evaluated by POCUS to find out the association between SMA blood flow and AGI.
Detailed description
- Patients are recruited within 24 hours of our surgical ICU admission. The patients are mostly admitted for post-surgery monitor in case of complications due to their baseline health conditions. In some cases, patients are admitted from the emergency room because of severe sickness. Those who are with deep sedation and mechanical ventilation during the first ultrasound evaluation are eligible for the study.
- Written informed consent was obtained from all patients or next of kin before the recruitment.
- Information will be collected at enrollment, including demographic characteristics, diagnosis, and so on.
- There will be two phases of ultrasound evaluation. In Phase One, investigators perform ultrasound evaluation within 24 hours after ICU admission to investigate the SMA blood flow in supine position using POCUS. In Phase Two, starting after the enteral feeding has been initiated, usually within 3 days after the enrollment, ultrasound evaluation on GI function will be performed according to gastrointestinal and urinary tract sonography ultrasound (GUTS) protocol using POCUS. GUTS protocol includes the ultrasound measurement for bowel diameter, bowel wall thickness, peristalsis combined with intra-abdominal pressure(IAP) measured through ureteral catheterization. All measurements would be used to calculate GUTS score to grade the AGI [4].
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted into the Department of Critical Care Medicine of Peking Union Medical College Hospital, who were eligible of inclusion criteria, were included in the study.
Key inclusion criteria (3 listed)
- 18 ~ 80 years old;
- Under deep sedation (RASS score ≤ -3) with mechanical ventilation at the time of enrollment;
- Acute Physiology and Chronic Health Evaluation II (APACHE-II) score ≥8.
Key exclusion criteria (5 listed)
- Pregnancy;
- Recent gastrointestinal surgery;
- History of acute or chronic gastrointestinal dysfunction before ICU admission;
- Primary or secondary vascular malformation of SMA;
- Any contraindication to the use of ultrasound evaluation (e.g., abdominal incision).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound examinationWe conduct abdominal ultrasound examinations for each patient. | Other | – |
Primary outcome
The occurence of acute gastrointestinal injury
Time frame: Within 24 hours after the initiation of enteral feeding
Gastrointestinal and urinary tract sonography ultrasound (GUTS) score will be calculate using a combination bowel diameter in centimeters, bowel wall thickness in centimeters, peristalsis (with or without) using ultrasound, and intra-abdominal pressure in millimeters of mercury measured through urethral tubes[3]. GUTS score is ranging from 0 to 4, and a higher GUTS score means worse gastrointestinal function. A GUTS score more than or equal to 2 is considered as acute gastrointestinal injury(AGI)in this study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Background: PubMed 23370829Reintam Blaser A, Poeze M, Malbrain ML, Bjorck M, Oudemans-van Straaten HM, Starkopf J; Gastro-Intestinal Failure Trial Group. Gastrointestinal symptoms during the first week of intensive care are associated with poor outcome: a prospective multicentre study. Intensive Care Med. 2013 May;39(5):899-909. doi: 10.1007/s00134-013-2831-1. Epub 2013 Jan 31.
- Background: PubMed 28092310Meng M, Klingensmith NJ, Coopersmith CM. New insights into the gut as the driver of critical illness and organ failure. Curr Opin Crit Care. 2017 Apr;23(2):143-148. doi: 10.1097/MCC.0000000000000386.
- Background: PubMed 9347197Perko MJ, Madsen P, Perko G, Schroeder TV, Secher NH. Mesenteric artery response to head-up tilt-induced central hypovolaemia and hypotension. Clin Physiol. 1997 Sep;17(5):487-96. doi: 10.1046/j.1365-2281.1997.05252.x.
- Background: PubMed 31775838Gao T, Cheng MH, Xi FC, Chen Y, Cao C, Su T, Li WQ, Yu WK. Predictive value of transabdominal intestinal sonography in critically ill patients: a prospective observational study. Crit Care. 2019 Nov 27;23(1):378. doi: 10.1186/s13054-019-2645-9.
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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.
Dawei Liu, MSc. study chair
Peking Union Medical College Hospital, Chinese Academy of Medical Science
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 Gastrointestinal Dysfunction and Critical Illness, run by Xinchen Wang at 1 site in China.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 4 Sep 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The occurence of acute gastrointestinal injury (time frame: Within 24 hours after the initiation of enteral feeding). 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 NCT04979494, which also lists 4 linked publications.
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 4 Sep 2024.