Intra-Abdominal HypertensionNCT05732545
Application of Enteral Nutrition Program in Patients With Intra-abdominal Hypertension Oriented by Intra-abdominal Pressure
A study testing enteral nutrition program for patients with abdominal hypertension guided by abdominal pressure in people with Intra-Abdominal Hypertension, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
In this study, relevant contents of the enteral nutrition nursing programs for severe patients with abdominal pressure were systematically searched, and quality evaluation was carried out based on existing evidence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-Abdominal Hypertension
- What is being tested?
- enteral nutrition program for patients with abdominal hypertension guided by abdominal pressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Nov 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria
- 12mmHg≤ intraperitoneal pressure ≤20mmHg (1mmHg=0.133kPa)
- ≥18 years of age
- Consistent with the indications of early enteral nutrition
- Patients with nutritional risk, gastrointestinal function, or partial gastrointestinal function and unable to eat through the mouth
- Stable hemodynamics (MAP > 65mmHg, blood lactic acid < 4mmol/L, and vasoactive drugs in the process of reduction or withdrawal)
- Patients or their family members sign the informed consent
- Exclusion Criteria
- Pregnant or lactating female patients
- Patients with recent abdominal surgery
- Patients with a large number of abdominal effusions;
- There are contraindications to enteral nutrition
- Uncontrolled shock
- Uncontrolled hypoxemia and acidosis
- Uncontrolled upper gastrointestinal bleeding
- GRV > 500mL/ 6h
- Intestinal ischemia
- Intestinal obstruction
- Abdominal space syndrome (ACS)
- High fistula without distal feeding
Trial locations and contacts
1 site in 1 country.
About this study
In this study, relevant contents of the enteral nutrition nursing programs for severe patients with abdominal pressure were systematically searched, and quality evaluation was carried out based on existing evidence. Based on evidence-based evidence, an enteral nutrition nursing program for patients with abdominal pressure was constructed, to improve the feed tolerance of patients with abdominal pressure, increase nutritional compliance rate, and improve patient prognosis.
Read the detailed description
Background: Enteral nutrition is the preferred method of artificial nutrition for critically ill patients. Early enteral nutrition within 24 to 48 hours after admission can maintain intestinal mucosal barrier function, increase local blood flow, reduce bacterial migration, and reduce the incidence of intestinal infections. Increased abdominal pressure is considered to be an independent risk factor for feeding intolerance in severe patients. Patients with abdominal pressure are prone to complications such as diarrhea, abdominal distension, vomiting, and even aspiration, which forces the suspension or suspension of enteral nutrition and leads to insufficient nutritional intake in patients. At present, there is evidence that regulating enteral nutrition through monitoring intra-abdominal pressure can effectively reduce the incidence of feeding intolerance in patients. Domestic and foreign scholars have formulated nutrition management programs for patients with intra-abdominal pressure from different aspects, such as monitoring and grading of intra-abdominal pressure, evaluation and management of tolerance, and prevention of complications. However, The standardized enteral nutrition feeding program oriented by the monitoring of intra-abdominal pressure has not yet formed a unified standard.
Objective: This study conducted a quality evaluation based on existing evidence, adopted evidence-based research methods to establish an enteral nutrition program for patients with abdominal hypertension oriented by abdominal pressure, and aimed to improve the feeding tolerance of patients with abdominal hypertension, improve the nutritional compliance rate and improve the prognosis of patients through the implementation of evidence-based practice programs.
- Conditions
- Intra-Abdominal Hypertension
- Being tested
- enteral nutrition program for patients with abdominal hypertension guided by abdominal pressure
- Keywords
- Intra-Abdominal Hypertention, Enteral Nutrition, Feeding Intolerance
- Medical subject headings
- Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutrition program for patients with abdominal hypertension guided by abdominal pressureBehavioural
There are 4 aspects of intra-abdominal pressure monitoring, source control and treatment for the etiology of increased abdominal pressure, enteral nutrition program, enteral nutrition tolerance evaluation and treatment
| Study group | Role | What they receive |
|---|---|---|
| enteral nutrition program by intra-abdominal pressure | Experimental | enteral nutrition program for patients with intra-abdominal hypertension guided by intra-abdominal pressure Receives: Behavioral: enteral nutrition program for patients with abdominal hypertension guided by abdominal pressure |
| Routine nursing measures | No intervention | Routine nursing measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of feeding intolerance
Incidence of feeding intolerance: refers to the frequency of new cases of feeding intolerance within 7 days after the initiation of enteral nutrition.
Measured: 7 days
Secondary outcomes (1)
The standard rate of feeding
Enteral nutrition feeding standard rate (%)=(actual feeding quantity ÷ target feeding quantity)×100%
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Jan 2022
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-Abdominal HypertensionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732545
- Sponsor's protocol ID
- 2021-0899
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 23 Feb 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 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Enteral Nutrition Program in Patients With Intra-abdominal Hypertension Oriented by Intra-abdominal Pressure
- ClinicalTrials.gov ID
- NCT05732545
- Acronym / sponsor ID
- 2021-0899
- Conditions
- Intra-Abdominal Hypertension
- Keywords
- Intra-Abdominal Hypertention, Enteral Nutrition, Feeding Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 17 Feb 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.
In this study, relevant contents of the enteral nutrition nursing programs for severe patients with abdominal pressure were systematically searched, and quality evaluation was carried out based on existing evidence. Based on evidence-based evidence, an enteral nutrition nursing program for patients with abdominal pressure was constructed, to improve the feed tolerance of patients with abdominal pressure, increase nutritional compliance rate, and improve patient prognosis.
Detailed description
Background: Enteral nutrition is the preferred method of artificial nutrition for critically ill patients. Early enteral nutrition within 24 to 48 hours after admission can maintain intestinal mucosal barrier function, increase local blood flow, reduce bacterial migration, and reduce the incidence of intestinal infections. Increased abdominal pressure is considered to be an independent risk factor for feeding intolerance in severe patients. Patients with abdominal pressure are prone to complications such as diarrhea, abdominal distension, vomiting, and even aspiration, which forces the suspension or suspension of enteral nutrition and leads to insufficient nutritional intake in patients. At present, there is evidence that regulating enteral nutrition through monitoring intra-abdominal pressure can effectively reduce the incidence of feeding intolerance in patients. Domestic and foreign scholars have formulated nutrition management programs for patients with intra-abdominal pressure from different aspects, such as monitoring and grading of intra-abdominal pressure, evaluation and management of tolerance, and prevention of complications. However, The standardized enteral nutrition feeding program oriented by the monitoring of intra-abdominal pressure has not yet formed a unified standard.
Objective: This study conducted a quality evaluation based on existing evidence, adopted evidence-based research methods to establish an enteral nutrition program for patients with abdominal hypertension oriented by abdominal pressure, and aimed to improve the feeding tolerance of patients with abdominal hypertension, improve the nutritional compliance rate and improve the prognosis of patients through the implementation of evidence-based practice programs.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enteral nutrition program by intra-abdominal pressure | Experimental | Behavioral: enteral nutrition program for patients with abdominal hypertension guided by abdominal pressureenteral nutrition program for patients with intra-abdominal hypertension guided by intra-abdominal pressure |
| Routine nursing measures | No intervention | –Routine nursing measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| enteral nutrition program for patients with abdominal hypertension guided by abdominal pressureThere are 4 aspects of intra-abdominal pressure monitoring, source control and treatment for the etiology of increased abdominal pressure, enteral nutrition program, enteral nutrition tolerance evaluation and treatment | Behavioural | enteral nutrition program by intra-abdominal pressure |
Primary outcome
Incidence of feeding intolerance
Time frame: 7 days
Incidence of feeding intolerance: refers to the frequency of new cases of feeding intolerance within 7 days after the initiation of enteral nutrition.
1 secondary outcome
The standard rate of feeding
Time frame: 7 days
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 23 Feb 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.
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?
A study testing enteral nutrition program for patients with abdominal hypertension guided by abdominal pressure in people with Intra-Abdominal Hypertension, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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?
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 23 Feb 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?
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?
Incidence of feeding intolerance (time frame: 7 days). 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 23 Feb 2023.