Acute PancreatitisNCT04525027
Predictive Ability of Intra-Abdominal Pressure for Mortality in Patients With Severe Acute Pancreatitis
An observational study of Acute Pancreatitis and Intra-Abdominal Hypertension, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Severe Acute Pancreatitis (SAP) is an acute inflammatory condition of the pancreas characterized by organ dysfunction and increased mortality. Increased Intra-abdominal Pressure(IAP) in SAP is a result of inflammation of pancreatic and peripancreatic tissue, aggressive fluid resuscitation and increased capillary… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Pancreatitis, Intra-Abdominal Hypertension
- What is being tested?
- intra-abdominal pressure in severe acute pancreatitis
- How many people
- 360 participants
- Where
- 1 siteIndia
- Study dates
- 26 Dec 2019to 20 Oct 2021
- 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 65 years
- All sexes
- Adult, Older adult
Study population: patients of acute severe pancreatitis admitted to ICU within 72 hours of symptom onset
Who may be able to join
- >Patients with severe acute pancreatitis in the age group of 18-65 years admitted to ICU within 72 hours of onset of symptoms
Who cannot join
- Previous history of any abdominal or pelvic surgery
- Known case of bladder tumor or bladder abnormality.
- Difficulty in urinary catheterization
- Use of neuromuscular blockade
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
India1 site
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
About this study
Official title: Predictive Ability of Intra-Abdominal Pressure for Mortality in Patients With Severe Acute Pancreatitis: A Prospective Observational Study
Severe Acute Pancreatitis (SAP) is an acute inflammatory condition of the pancreas characterized by organ dysfunction and increased mortality. Increased Intra-abdominal Pressure(IAP) in SAP is a result of inflammation of pancreatic and peripancreatic tissue, aggressive fluid resuscitation and increased capillary permeability, which is associated with organ dysfunction, by limiting the vascular supply to the tissue. Abdominal Compartment Syndrome (ACS) is defined as IAP greater than 20 mm of Hg and is considered an abdominal catastrophe. Intra-abdominal Hypertension (IAH, Intra-abdominal pressure > 12mm of Hg), may contribute to early organ dysfunction, ACS and eventually hemodynamic collapse if left untreated. This signifies the need for determining the burden of the condition and identifying the high risk patient group who are prone to develop IAH /ACS and predicting mortality associated with the condition. Measurement of IAP will be done indirectly by measuring intravesicular pressure using modified kron's method. IAP will be measured at the time of admission into Intensive Care Unit (ICU) and every day thereafter during the initial five days of ICU admission. Any reading of IAP ≥12 mm of Hg shall be considered as IAH. SOFA and APACHE II score will be noted on the day of admission in the ICU. Any interventions, surgical or non surgical as per clinician's decision will be recorded. The patients will be followed up until discharge or mortality until 30 days. The proposed study aims to assess the predictive ability of IAP during the first 5 days of ICU admission for predicting mortality in patients with SAP. Prediction accuracy will also be compared with SOFA and APACHE II scores.
- Conditions
- Acute Pancreatitis, Intra-Abdominal Hypertension
- Being tested
- intra-abdominal pressure in severe acute pancreatitis
- Keywords
- severe acute pancreatitis, intra abdominal pressure, mortality, intra abdominal hypertension
- Medical subject headings
- Pancreatitis, Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-abdominal pressure in severe acute pancreatitisDiagnostic test
daily intra abdominal pressures in patients admitted to ICU will be measured and noted for intial 5 days and followed up until end outcome
| Study group | Role | What they receive |
|---|---|---|
| survivors | Not described Receives: Diagnostic Test: intra-abdominal pressure in severe acute pancreatitis | |
| non survivors | Not described Receives: Diagnostic Test: intra-abdominal pressure in severe acute pancreatitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 30 days from inclusion date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start26 Dec 2019
- Primary completion20 Oct 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- 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
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Ganga Ram Hospital
- Responsible party
- Principal investigator, VAMSIDHAR, Sir Ganga Ram Hospital
- Investigators
- vinod singh, MD, Study chair, Sir Ganga Ram Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525027
- Sponsor's protocol ID
- EC/12/19/1650
- Status last verified
- Mar 2023
- First submitted
- 18 Aug 2020
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Ability of Intra-Abdominal Pressure for Mortality in Patients With Severe Acute Pancreatitis: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04525027
- Acronym / sponsor ID
- EC/12/19/1650
- Conditions
- Acute Pancreatitis, Intra-Abdominal Hypertension
- Keywords
- severe acute pancreatitis, intra abdominal pressure, mortality, intra abdominal hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Collaborators
- Sir Ganga Ram Hospital
- Study start
- 26 Dec 2019 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 24 Aug 2020 (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.
Severe Acute Pancreatitis (SAP) is an acute inflammatory condition of the pancreas characterized by organ dysfunction and increased mortality. Increased Intra-abdominal Pressure(IAP) in SAP is a result of inflammation of pancreatic and peripancreatic tissue, aggressive fluid resuscitation and increased capillary permeability, which is associated with organ dysfunction, by limiting the vascular supply to the tissue. Abdominal Compartment Syndrome (ACS) is defined as IAP greater than 20 mm of Hg and is considered an abdominal catastrophe. Intra-abdominal Hypertension (IAH, Intra-abdominal pressure > 12mm of Hg), may contribute to early organ dysfunction, ACS and eventually hemodynamic collapse if left untreated. This signifies the need for determining the burden of the condition and identifying the high risk patient group who are prone to develop IAH /ACS and predicting mortality associated with the condition. Measurement of IAP will be done indirectly by measuring intravesicular pressure using modified kron's method. IAP will be measured at the time of admission into Intensive Care Unit (ICU) and every day thereafter during the initial five days of ICU admission. Any reading of IAP ≥12 mm of Hg shall be considered as IAH. SOFA and APACHE II score will be noted on the day of admission in the ICU. Any interventions, surgical or non surgical as per clinician's decision will be recorded. The patients will be followed up until discharge or mortality until 30 days. The proposed study aims to assess the predictive ability of IAP during the first 5 days of ICU admission for predicting mortality in patients with SAP. Prediction accuracy will also be compared with SOFA and APACHE II scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| survivors | – | Diagnostic Test: intra-abdominal pressure in severe acute pancreatitis |
| non survivors | – | Diagnostic Test: intra-abdominal pressure in severe acute pancreatitis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients of acute severe pancreatitis admitted to ICU within 72 hours of symptom onset
Key inclusion criteria (1 listed)
- >Patients with severe acute pancreatitis in the age group of 18-65 years admitted to ICU within 72 hours of onset of symptoms
Key exclusion criteria (5 listed)
- Previous history of any abdominal or pelvic surgery
- Known case of bladder tumor or bladder abnormality.
- Difficulty in urinary catheterization
- Use of neuromuscular blockade
- Pregnant patients
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 |
|---|---|---|
| intra-abdominal pressure in severe acute pancreatitisdaily intra abdominal pressures in patients admitted to ICU will be measured and noted for intial 5 days and followed up until end outcome | Diagnostic test | non survivors, survivors |
Primary outcome
Mortality
Time frame: 30 days from inclusion date
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 3 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
vinod singh, MD study chair
Sir Ganga Ram Hospital
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 Pancreatitis and Intra-Abdominal Hypertension, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 1 inclusion and 5 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 3 Apr 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 India. 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?
Mortality (time frame: 30 days from inclusion date). 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 3 Apr 2023.