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Acute Gastrointestinal InjuryNCT06667297

Correlation Between Acute Gastrointestinal Injury and Venous Return in Critical Ill Patients

An observational study of Acute Gastrointestinal Injury and Critical Illness, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Currently, altered intestinal blood flow in critically ill patients has been a hot research topic in recent years. In 2022, studies on acute mesenteric ischemia were published in top journals in critical care medicine [Crit Care, 2022. 26(1): p.92. and Intensive Care Med, 2022. 26(2): p.92.]. Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
200 participants
Where
1 siteChina
Study dates
1 May 2023to 30 Jul 2025
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: Adult ICU admitted patients in comprehensive hospital

Who may be able to join

  • Patients with sepsis with an expected ICU stay of more than 3 days.
  • ≥18 years of age and <80 years of age.

Who cannot join

  • Severe mesenteric or abdominal artery stenosis;
  • Fixed body (such as recent spinal surgery or intracranial hypertension);
  • Patients with contraindications for IAP measurement (such as patients who have recently undergone bladder surgery, been injured, or become pregnant)
  • Having undergone abdominal surgery or chest lowering involving the intestines patients undergoing aortic surgery;
  • Poor quality of abdominal ultrasound images;
  • Hydrothorax or ascites.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Department of Critical Care Medicine of pekin union medical college hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Currently, altered intestinal blood flow in critically ill patients has been a hot research topic in recent years. In 2022, studies on acute mesenteric ischemia were published in top journals in critical care medicine [Crit Care, 2022. 26(1): p.92. and Intensive Care Med, 2022. 26(2): p.92.].

However, because the gastrointestinal tract is in the abdominal cavity and doctors lack methods to directly monitor the visceral perfusion. Therefore, there is little research on the relationship between gastrointestinal perfusion and acute gastrointestinal injury in critical ill patients. Currently, the diagnosis of acute gastrointestinal injury is mostly performed using subjective indicators and adverse outcomes that have already occurred, which results in the treatment of acute gastrointestinal injury often lagging behind.

Read more

The use of color Doppler ultrasonography to assess blood flow in intestinal vessels in healthy and outpatient patients has been in use since the 1980s. Our team showed that the resistance index of the superior mesenteric artery(SMA) in postoperative cardiac surgery patients correlated with lactate values and lactate clearance [Front Med (Lausanne), 2021.8: p.762376.], suggesting that gastrointestinal perfusion as reflected by SMA blood flow is important for systemic resuscitation, and that Doppler indices of SMA have the potential value of reflecting intestinal hypo-perfusion.

Intestinal venous blood enters the portal vein and then the liver before returning to the right heart via the inferior vena cava. Right ventricular dysfunction or abdominal hypertension could cause obstruction of portal venous return, which might lead to edema and dysfunction of the intestine.

Therefore, monitoring the venous return status is crucial for intestinal perfusion.

In 2012, the Venous Excess Ultrasound Score(VExUS) for evaluating venous return has been reported and it has been shown to correlate with acute kidney injury (AKI) [Intensive Care Med, 2012. 38(3): p.384-94]. However, there is currently no research on the correlation between acute gastrointestinal injury and venous return, and this study is innovative and exploratory.

Read the detailed description

Research Methods

  1. The Venous Excess Ultrasound Score(VExUS): Blood flow parameters were measured by two ICU physicians and the mean values were recorded. Both ICU physicians had more than 4 years of experience in critical care ultrasound; they were certified by the Chinese Critical Care Ultrasound Study Group. Monitoring the status of venous return in the portal vein, hepatic vein, intra-renal vein. The status of venous returnwere evaluated in categorical variables as normal, mildly abnormal, or severely abnormal, as previously reported. Patients were then classified according to the assessment in Grades 0-3: Grade 0, no congestion; Grade 1, mild congestion; Grade 2, moderate congestion; and Grade 3, severe congestion.To minimize errors, it is important to take the average of three measurements in a magnified state.
  2. Ultrasound score of transabdominal bowel function (AGUIS score) At the time of the ultrasound examination, the operator categorized the situation as "good quality", "poor quality" or "not assessable". The abdomen is then divided into four quadrants, each measuring one point, and the operator examines and scores the diameter of the bowel, changes in bowel folds (e.g., shortening, decreasing), thickness of the bowel wall, layering of the bowel wall, peristalsis, and movement of bowel contents. A total of four scores are obtained, and the average of the four measurements is the (AGIUS) score.
  3. Gastrointestinal Dysfunction Score (GIDS): 0 score (No risk): No symptoms OR one of the following with oral intake: Absent bowel sounds; Vomiting; GRV >200 mL; GI paralysis/dynamic ileus; Abdominal distension; Diarrhea (not severe); GI bleeding without transfusion; IAP >20 mmHg. 1 score(Increased risk): Two of the following: No oral intake; Absent bowel sounds; Vomiting; GRV >200 mL; GI paralysis/dynamic ileus; Abdominal distension; Diarrhea (not severe); GI bleeding without transfusion; IAP >20 mmHg. 2 score(gastrointestinal dysfunction): Three or more symptoms of score 1 OR up to two of the following: Severe diarrhea; GI bleeding with transfusion; IAP >20 mmHg. 3 score(gastrointestinal failure): Three or more of the following: Prokinetic use; GI paralysis/dynamic ileus; Abdominal distension; Severe diarrhea; GI bleeding with transfusion; IAP >20 mmHg. 4 score(Life threatening): One of the following: GI bleeding leading to hemorrhagic shock; Mesenteric ischemia; Abdominal compartment syndrome
  4. Serologic indices of intestinal mucosal epithelial injury Plasma citrulline, plasma intestinal fatty acid binding protein, and D-lactic acid were measured by ELISA. (R\&D Systems, Minneapolis, USA). Peripheral blood specimens were obtained and centrifuged, and the resulting plasma was frozen at -20°C and sent to the laboratory for analysis within 1 week.

Study Route:

On the day of enrollment, patients' hemodynamic parameters, measurement of VExUS, AGUIS score, GIDS score and serum specimen were recorded. Measurement of the above parameters was repeated at Day 1(ICU admission),Day 2(between 24 and 48 h),Day 3(between 48 and 72 h),and Departure Day(ICU discharge).

Keywords
Acute gastrointestinal injury, Venous Excess Ultrasound Score
Medical subject headings
Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Venous Excess Ultrasound Score

    The study primary endpoint was the VExUS score. It was calculated four times during the ICU stay: within 24 h of ICU admission, after day 1 (between 24 and 48 h), after day 2 (between 48 and 72 h), and at ICU discharge. The patients were classified as being congestive (VExUS≥2) or not being congestive (VExUS < 2). A VExUS grade 2 was defined as moderate congestion, and a VExUS grade 3 was defined as severe congestion.

    Measured: Day 1(ICU admission),Day 2(between 24 and 48 h),Day 3(between 48 and 72 h),Departure Day(ICU discharge)

Secondary outcomes (3)
  1. Serologic indices of intestinal mucosal epithelial injury Plasma citrulline, plasma intestinal fatty acid binding protein, and D-lactic acid

    Those indices were measured by ELISA. (R\&D Systems, Minneapolis, USA). Peripheral blood specimens were obtained and centrifuged, and the resulting plasma was frozen at -20°C and sent to the laboratory for analysis within 1 week

    Measured: Day 1(ICU admission),Day 2(between 24 and 48 h),Day 3(between 48 and 72 h),Departure Day(ICU discharge)

  2. Acute gastrointestinal injury

    The severity of acute gastrointestinal injury is classified based on the American Association for the Surgery of Trauma (AAST) grading system. The system assigns grades from I to V, with I being the least severe and V being the most severe. Grade I injuries involve minimal damage to the mucosa and submucosa of the gastrointestinal tract. Grade II injuries involve damage to the muscularis propria layer. Grade III injuries involve damage to all layers of the gastrointestinal wall, but there is no perforation or major organ dysfunction. Grade IV injuries involve perforation or major organ dysfunction. Grade V injuries are associated with necrotic bowel or mesenteric ischemia.

    Measured: Day 1(ICU admission),Day 2(between 24 and 48 h),Day 3(between 48 and 72 h),Departure Day(ICU discharge)

  3. GIDS

    a new Gastrointestinal Dysfunction Score (GIDS) for critically ill patients based on the rationale of the previously developed AGI grading system, which is similarly divided into five grades(from 0 to 4). 0=No risk ;1=Increased risk ;2=gastrointestinal dysfunction; 3= gastrointestinal failure; 4=Life threatening.

    Measured: Day 1(ICU admission),Day 2(between 24 and 48 h),Day 3(between 48 and 72 h),Departure Day(ICU discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2024
  2. Study start1 May 2023
  3. Primary completion30 Nov 2024
  4. Study completion30 Jul 2025

Resources

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
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06667297
Sponsor's protocol ID
216-3
Status last verified
Oct 2024
First submitted
17 Jan 2024
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Gastrointestinal Injury and Critical Illness, run by Peking Union Medical College Hospital 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 2 inclusion and 6 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 5 Sep 2025. 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 Venous Excess Ultrasound Score (time frame: Day 1(ICU admission),Day 2(between 24 and 48 h),Day 3(between 48 and 72 h),Departure Day(ICU discharge)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Sep 2025.

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