Critically Ill PatientsNCT06049979
Correlation Between Intestinal Blood Flow and Intestinal Dysfunction in Critically Ill Patients
An observational study of Critically Ill Patients, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Currently in the field of critical care, altered intestinal blood flow in critically ill patients has been a hot research topic in recent years. However, because the gastrointestinal tract is in the abdominal cavity and the clinic lacks perfusion direct monitoring means, at present, gastrointestinal function… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critically Ill Patients
- What is being tested?
- Acute gastrointestinal injury
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 May 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
- Coronary heart disease, 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, 1 recruiting
- Recruiting
Department of Critical Care Medicine of pekin union medical college hospital
Beijing, Beijing Municipality, 100730
Yuankai Zhou, MD, 010-69152300, zhouyuankai@aliyun.com
About this study
Currently in the field of critical care, altered intestinal blood flow in critically ill patients has been a hot research topic in recent years. However, because the gastrointestinal tract is in the abdominal cavity and the clinic lacks perfusion direct monitoring means, at present, gastrointestinal function indicators are mostly used to guide the clinic, and the treatment is often blind and lagging. Gastrointestinal perfusion Research on gastrointestinal perfusion is mostly confined to abdominal perfusion pressure (mean arterial pressure - intra-abdominal pressure). However, according to the "Darcy law" in blood flow mechanics, Q=MAP/SVR, which means pressure≠flow. The investigators may not be able to ensure adequate blood flow to the digestive organs by relying on intra-abdominal perfusion pressure alone. Direct organ flow monitoring is a more accurate means of organization.
The superior mesenteric artery (SMA) supplies all of the intestinal tract (small bowel, part of the colon) and is a long vessel that can to reflect the perfusion status of the distal overall bowel. Color Doppler ultrasonography is used to evaluate intestinal vessels such as the SMA in healthy and outpatient patients.
Read more
The use of color Doppler ultrasonography to assess blood flow in intestinal vessels such as the SMA in healthy and outpatient patients has been in use since the 1980s. The investigators' team showed that the resistance index of the 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 hypoperfusion.
The Doppler index of SMA has the potential value of reflecting intestinal hypoperfusion. Intestinal venous blood enters the portal vein and then the liver before returning to the right heart via the inferior vena cava. Right heart dysfuction, right atrial hypertension, and abdominal hypertension can cause obstruction of portal venous return, which can lead to edema and dysfunction of the bowel. This can lead to edema of the intestinal tract and dysfunction. Therefore, monitoring the venous return status of portal vein, hepatic vein and inferior vena cava is also important for the perfusion of the intestine.
Therefore, monitoring the status of venous return in the portal vein, hepatic vein, inferior vena cava, etc. is also important for intestinal perfusion.
Doppler ultrasound technology has been widely used in the field of cardiac critical care and craniocerebral critical care, but it is still in the exploratory stage in the field of critical care digestion, and this study is an innovative and exploratory one.
Read the detailed description
Research Methods
(1) Doppler ultrasound technique for intestinal blood flow assessment:An ultrasound system (X-Porte Ultrasound System, FUJIFILM SONOSITE, INC., USA) consisting of a 2-5 MHz C60xp probe was performed. 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. SMA flow was measured 1 cm proximal to the abdominal aorta. The insertion angle was <60° . The vessel cross-section was circular. The probe was rotated 90° where the vessel flow was measured and the diameter of the lumen (D) was measured. To minimize errors, it is important to take the average of three measurements in a magnified state. The cross-sectional area of the artery is calculated. Peak systolic velocity (PSV), end-diastolic velocity (EDV), resistance index (RI), time-averaged mean velocity (TAMV), pulsatility index (PI), and blood flow (BF, mL/min) were measured using time-velocity waveform readings according to the calculation software carried by the sonographer. BF=π(D/2)²×TAMV×60, PI=(PSV-EDV)/TAMV, RI=(PSV-EDV)/PSV.
- 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 operator categorizes the situation as "good quality," "poor quality," or "not evaluable. 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) 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:
Patients with sepsis who met the inclusion criteria were enrolled on the day of enrollment to improve the recording of hemodynamic parameters, measurement of Doppler parameters of intestinal blood flow, and serum specimen retention. Measurements of the above parameters were repeated daily from the first to the third day.
- Conditions
- Critically Ill Patients
- Being tested
- Acute gastrointestinal injury
- Keywords
- Intestinal Blood Flow, Acute gastrointestinal injury, Critically Ill Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute gastrointestinal injuryOther
AGIUS score>2
| Study group | Role | What they receive |
|---|---|---|
| AGI group | critical ill patient with AGIUS score>2 Receives: Other: Acute gastrointestinal injury | |
| non-AGI group | critical ill patient with AGIUS score 0~2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal Ultrasound Score (AGIUS)
Quantitative scoring is performed by using ultrasound to evaluate intestinal diameter, intestinal wall thickness, and motility. The range is 0-6 points. 0 is the best, 6 is the worst
Measured: Day 1，Day 2，Day 3
pulsatile index of superior mesenteric artery
pulsatile index of superior mesenteric artery
Measured: Day 1，Day 2，Day 3
Secondary outcomes (3)
Sequential Organ Failure Assessment（SOFA）
Sequential Organ Failure Assessment
Measured: Day 1，Day 2，Day 3
Mechanical ventilation duration
Mechanical ventilation duration
Measured: Total time left from ICU or within 28 days
28 day mortality rate
28 day mortality rate
Measured: Within 28 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 May 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill PatientsStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Long, MD, Study chair, PUMCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049979
- Sponsor's protocol ID
- 2023-PUMCH-A-216
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 22 Sep 2023
- 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Intestinal Blood Flow and Intestinal Dysfunction in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06049979
- Acronym / sponsor ID
- 2023-PUMCH-A-216
- Conditions
- Critically Ill Patients
- Keywords
- Intestinal Blood Flow, Acute gastrointestinal injury, Critically Ill Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 22 Sep 2023 (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 in the field of critical care, altered intestinal blood flow in critically ill patients has been a hot research topic in recent years. However, because the gastrointestinal tract is in the abdominal cavity and the clinic lacks perfusion direct monitoring means, at present, gastrointestinal function indicators are mostly used to guide the clinic, and the treatment is often blind and lagging. Gastrointestinal perfusion Research on gastrointestinal perfusion is mostly confined to abdominal perfusion pressure (mean arterial pressure - intra-abdominal pressure). However, according to the "Darcy law" in blood flow mechanics, Q=MAP/SVR, which means pressure≠flow. The investigators may not be able to ensure adequate blood flow to the digestive organs by relying on intra-abdominal perfusion pressure alone. Direct organ flow monitoring is a more accurate means of organization.
The superior mesenteric artery (SMA) supplies all of the intestinal tract (small bowel, part of the colon) and is a long vessel that can to reflect the perfusion status of the distal overall bowel. Color Doppler ultrasonography is used to evaluate intestinal vessels such as the SMA in healthy and outpatient patients.
The use of color Doppler ultrasonography to assess blood flow in intestinal vessels such as the SMA in healthy and outpatient patients has been in use since the 1980s. The investigators' team showed that the resistance index of the 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 hypoperfusion.
The Doppler index of SMA has the potential value of reflecting intestinal hypoperfusion. Intestinal venous blood enters the portal vein and then the liver before returning to the right heart via the inferior vena cava. Right heart dysfuction, right atrial hypertension, and abdominal hypertension can cause obstruction of portal venous return, which can lead to edema and dysfunction of the bowel. This can lead to edema of the intestinal tract and dysfunction. Therefore, monitoring the venous return status of portal vein, hepatic vein and inferior vena cava is also important for the perfusion of the intestine.
Therefore, monitoring the status of venous return in the portal vein, hepatic vein, inferior vena cava, etc. is also important for intestinal perfusion.
Doppler ultrasound technology has been widely used in the field of cardiac critical care and craniocerebral critical care, but it is still in the exploratory stage in the field of critical care digestion, and this study is an innovative and exploratory one.
Detailed description
Research Methods
(1) Doppler ultrasound technique for intestinal blood flow assessment:An ultrasound system (X-Porte Ultrasound System, FUJIFILM SONOSITE, INC., USA) consisting of a 2-5 MHz C60xp probe was performed. 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. SMA flow was measured 1 cm proximal to the abdominal aorta. The insertion angle was <60° . The vessel cross-section was circular. The probe was rotated 90° where the vessel flow was measured and the diameter of the lumen (D) was measured. To minimize errors, it is important to take the average of three measurements in a magnified state. The cross-sectional area of the artery is calculated. Peak systolic velocity (PSV), end-diastolic velocity (EDV), resistance index (RI), time-averaged mean velocity (TAMV), pulsatility index (PI), and blood flow (BF, mL/min) were measured using time-velocity waveform readings according to the calculation software carried by the sonographer. BF=π(D/2)²×TAMV×60, PI=(PSV-EDV)/TAMV, RI=(PSV-EDV)/PSV.
- 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 operator categorizes the situation as "good quality," "poor quality," or "not evaluable. 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) 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:
Patients with sepsis who met the inclusion criteria were enrolled on the day of enrollment to improve the recording of hemodynamic parameters, measurement of Doppler parameters of intestinal blood flow, and serum specimen retention. Measurements of the above parameters were repeated daily from the first to the third day.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGI group | – | Other: Acute gastrointestinal injurycritical ill patient with AGIUS score>2 |
| non-AGI group | – | –critical ill patient with AGIUS score 0~2 |
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)
- Coronary heart disease, 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute gastrointestinal injuryAGIUS score>2 | Other | AGI group |
Primary outcome
Intestinal Ultrasound Score (AGIUS)
Time frame: Day 1，Day 2，Day 3
Quantitative scoring is performed by using ultrasound to evaluate intestinal diameter, intestinal wall thickness, and motility. The range is 0-6 points. 0 is the best, 6 is the worst
pulsatile index of superior mesenteric artery
Time frame: Day 1，Day 2，Day 3
pulsatile index of superior mesenteric artery
3 secondary outcomes
Sequential Organ Failure Assessment（SOFA）
Time frame: Day 1，Day 2，Day 3
Mechanical ventilation duration
Time frame: Total time left from ICU or within 28 days
28 day mortality rate
Time frame: Within 28 days after ICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- 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.
Yun Long, MD study chair
PUMCH
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 Critically Ill Patients, 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: status not confirmed, as of the sponsor's last update on 22 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuankai Zhou, MD (+00886-10-69152300, zhouyuankai@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal Ultrasound Score (AGIUS) (time frame: Day 1，Day 2，Day 3). The study lists 2 primary outcomes in all. 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 22 Sep 2023.