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

NCT06667297 | Completed

• 1 other identifier: 216-3
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 \[Crit Care, 2022. 26(1): p.92. and Intensive Care Med, 2022. 26(2): p.92.\]. 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.

Conditions

Acute Gastrointestinal Injury; Critical Illness

Keywords

Acute gastrointestinal injury; Venous Excess Ultrasound Score

Outcome Measures

Primary Outcomes (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.

  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

  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

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

• GIDS

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult ICU admitted patients in comprehensive hospital

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of Critical Care Medicine of pekin union medical college hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: October 31, 2024
• Study Start: May 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: July 30, 2025
• Last Updated: September 5, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)