Association Between SMA Flow and AGI in Critically Ill Patients

NCT ID: NCT04979494

Last Updated: 2024-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-09-30

Brief Summary

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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

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1. 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.
2. Written informed consent was obtained from all patients or next of kin before the recruitment.
3. Information will be collected at enrollment, including demographic characteristics, diagnosis, and so on.
4. 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

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Gastrointestinal Dysfunction Critical Illness

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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ultrasound examination

We conduct abdominal ultrasound examinations for each patient.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 18 \~ 80 years old;
2. Under deep sedation (RASS score ≤ -3) with mechanical ventilation at the time of enrollment;
3. Acute Physiology and Chronic Health Evaluation II (APACHE-II) score ≥8.

Exclusion Criteria

1. Pregnancy;
2. Recent gastrointestinal surgery;
3. History of acute or chronic gastrointestinal dysfunction before ICU admission;
4. Primary or secondary vascular malformation of SMA;
5. Any contraindication to the use of ultrasound evaluation (e.g., abdominal incision).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinchen Wang

OTHER

Sponsor Role lead

Responsible Party

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Xinchen Wang

Attending Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dawei Liu, MSc.

Role: STUDY_CHAIR

Peking Union Medical College Hospital, Chinese Academy of Medical Science

Locations

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Peking Union Medical College Hospital, Chinese Academy of Medical Science

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 23370829 (View on PubMed)

Meng 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.

Reference Type BACKGROUND
PMID: 28092310 (View on PubMed)

Perko 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.

Reference Type BACKGROUND
PMID: 9347197 (View on PubMed)

Gao 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.

Reference Type BACKGROUND
PMID: 31775838 (View on PubMed)

Other Identifiers

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PUMCH-JS-2687

Identifier Type: -

Identifier Source: org_study_id

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