Association Between SMA Flow and AGI in Critically Ill Patients

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04979494
Collaborator
(none)
60
1
12.9
4.6

Study Details

Study Description

Brief 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). 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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].

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Sep 1, 2020
    Anticipated Primary Completion Date :
    Sep 1, 2021
    Anticipated Study Completion Date :
    Sep 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Post cardiac surgery

    Patients admitted to ICU right after cardiac surgery with or without cardiopulmonary bypass, usually with cardiac shock.

    Sepsis and septic shock

    Patients admitted to ICU with the major complication of sepsis or septic shock.

    Control

    Patients admitted to ICU for post-surgery monitor in case of complications due to their baseline health condition(e.g. coronary artery disease, hypertension and so on), but without severe shock.

    Outcome Measures

    Primary Outcome Measures

    1. The occurence of acute gastrointestinal injury [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital, Chinese Academy of Medical Science Beijing China

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    • Study Chair: Dawei Liu, MSc., Peking Union Medical College Hospital, Chinese Academy of Medical Science

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT04979494
    Other Study ID Numbers:
    • PUMCH-JS-2687
    First Posted:
    Jul 28, 2021
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    Jun 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking Union Medical College Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2021