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.
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
- Conditions the study is for
- Acute Gastrointestinal Injury, Critical Illness
- 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
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
- 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.
- 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.
- 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
- 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).
- Conditions
- Acute Gastrointestinal Injury, Critical Illness
- 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.
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)
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)
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)
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.
- First posted31 Oct 2024
- Study start1 May 2023
- Primary completion30 Nov 2024
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Gastrointestinal InjuryStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Acute Gastrointestinal Injury and Venous Return in Critical Ill Patients
- ClinicalTrials.gov ID
- NCT06667297
- Acronym / sponsor ID
- 216-3
- Conditions
- Acute Gastrointestinal Injury, Critical Illness
- Keywords
- Acute gastrointestinal injury, Venous Excess Ultrasound Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 31 Oct 2024 (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.
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.
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.
Detailed description
Research Methods
- 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.
- 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.
- 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
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU admitted patients in comprehensive hospital
Key inclusion criteria (2 listed)
- Patients with sepsis with an expected ICU stay of more than 3 days.
- ≥18 years of age and <80 years of age.
Key exclusion criteria (6 listed)
- 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;
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
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)
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.
3 secondary outcomes
Serologic indices of intestinal mucosal epithelial injury Plasma citrulline, plasma intestinal fatty acid binding protein, and D-lactic acid
Time frame: Day 1(ICU admission),Day 2(between 24 and 48 h),Day 3(between 48 and 72 h),Departure Day(ICU discharge)
Acute gastrointestinal injury
Time frame: Day 1(ICU admission),Day 2(between 24 and 48 h),Day 3(between 48 and 72 h),Departure Day(ICU discharge)
GIDS
Time frame: Day 1(ICU admission),Day 2(between 24 and 48 h),Day 3(between 48 and 72 h),Departure Day(ICU discharge)
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 5 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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.