Severe SepsisPhase 4MUNI-SEPNCT05895240
Role of Ulinastatin in Preventing Severe Sepsis and Consequent Morbidities and Mortality
A Phase 4 study testing Ulinastatin in people with Severe Sepsis and Septic Shock, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial summary
The study will enhance the theory in the frame of reference on the efficacy of Ulinastatin while managing sepsis and subsequent morbidity and mortality. Moreover, the present study will explore Ulinastatin's prophylactic role in progression of multiple organ dysfunctions. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Severe Sepsis, Septic Shock, MODS
- What is being tested?
- Ulinastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2023to Oct 2023
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age >18 or <60
- Sepsis, and severe sepsis, as defined in operational definitions
- Patients voluntarily agreed to participate in the study after informed consent
Who cannot join
- Fulminant hepatic failure
- Acute cerebrovascular accidents
- Acute poisoning
- Chronic Kidney Disease stage 5
- Diagnosed case of immune thrombocytopenia
- Low output cardiac failure, with left ventricular ejection fraction <20%
- Advance chronic obstructive pulmonary disease on long term oxygen therapy
- Lactation or pregnancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Medical ICU, Jinnah Postgraduate Medical Centre
Karachi, Sindh, 71550
Zeeshan Ali, FCPS, +923211000393, dr.zeeshan.j@gmail.com
Shamim Kausar, FCPS, +923343093627, drshamimahsan@gmail.com
About this study
Official title: MUNI-SEP TRIAL-The Role of Ulinastatin in Preventing Severe Sepsis and Consequent Morbidities and Mortality; A Randomized Clinical Trial in Pakistan.
The study will enhance the theory in the frame of reference on the efficacy of Ulinastatin while managing sepsis and subsequent morbidity and mortality. Moreover, the present study will explore Ulinastatin's prophylactic role in progression of multiple organ dysfunctions. Furthermore, the study will have the clinical implications in predicting the ICU admitted patient's stay and related cost in the context of new drug. Current researches will explore the new dimensions in Pakistan's healthcare facilities, paving the way of future academics to analyze it in order to enhance healthcare outcomes.
Read the detailed description
The current study is a randomised clinical trial with the aim of exploring the following objectives in the context of Pakistan:
- To determine the efficacy of Ulinastatin in preventing the progression of Sepsis to Severe Sepsis and septic shock.
- To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients.
- To investigate the impact of Ulinastatin on sepsis associated mortality and morbidity.
- To explore the role of Ulinastatin in reducing ICU stays and associated costs in defined patients.
- To provides a condensed basis to understand ULINASTATIN as a sepsis management drug.
- Conditions
- Severe Sepsis, Septic Shock, MODS
- Being tested
- Ulinastatin
- Medical subject headings
- Sepsis, Shock, Septic, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlinastatinDrug
Nine MiU Ulinastatin in three divided doses 8 hourly for 3-5 days
| Study group | Role | What they receive |
|---|---|---|
| Control Group Arm | No intervention | Standard of care treatment arm, study medication will not be given |
| Active Intervention Arm | Experimental | This group will receive Nine MiU Ulinastatin in three divided doses 8 hourly Receives: Drug: Ulinastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of MOD's in patients with sepsis
To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients. Sepsis is defnied as evidence of infection (positive culture of blood, Urine, Tracheal) or suspected infection (by a physician) plus 2 out of 4 criteria's of SIRS. MODS is presence of two or more organ dysfunction with scoring ≥2 of each organ as per Sequential Organ Failure Assessment (SOFA) score.
Measured: Day 1 of enrollment
Prevention of MOD's in patients with sepsis
To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients. Sepsis is defnied as evidence of infection (positive culture of blood, Urine, Tracheal) or suspected infection (by a physician) plus 2 out of 4 criteria's of SIRS. MODS is presence of two or more organ dysfunction with scoring ≥2 of each organ as per Sequential Organ Failure Assessment (SOFA) score.
Measured: Day 3 of enrollment
Prevention of MOD's in patients with sepsis
To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients. Sepsis is defnied as evidence of infection (positive culture of blood, Urine, Tracheal) or suspected infection (by a physician) plus 2 out of 4 criteria's of SIRS. MODS is presence of two or more organ dysfunction with scoring ≥2 of each organ as per Sequential Organ Failure Assessment (SOFA) score.
Measured: Day 5 of enrollment
Effect on in-hospital mortality
To investigate the impact of Ulinastatin on sepsis associated mortality.
Measured: During first 48 hours of hospital stay after enrollment
Effect on 7 days mortality
To investigate the impact of Ulinastatin on sepsis associated mortality.
Measured: During the 7 days of enrollment
Effect on 14 days mortality
To investigate the impact of Ulinastatin on sepsis associated mortality.
Measured: During the 14 days of enrollment
Effect on 28 days mortality
To investigate the impact of Ulinastatin on sepsis associated mortality.
Measured: During the 28 days of enrollment
Secondary outcomes (4)
Number of days on mechanical ventilation
To explore the role of Ulinastatin in reducing the number of days on mechanical ventilation
Measured: Up to 28 days after enrollment
Number of days in ICU
To explore the role of Ulinastatin in reducing ICU stays.
Measured: Up to 28 days after enrollment
Prevention of Severe Sepsis in patients admitted with Sepsis
To determine the efficacy of Ulinastatin in preventing the progression of sepsis to severe sepsis. Severe sepsis is sepsis as defined above plus at least one organ/system dysfunction scoring ≥ 2 as per Sequential Organ Failure Assessment (SOFA) score.
Measured: Up to 28 days after enrollment
Prevention of Septic Shock in patients admitted with Sepsis
To determine the efficacy of Ulinastatin in preventing the progression of sepsis to septic shock. Septic shock is persistent hypotension requiring vasopressors to maintain mean arterial pressure of 65mmHg or higher and a serum lactate level greater than 2mmol/L despite adequate volume resuscitation with 30ml/kg of crystalloid solution.
Measured: Up to 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 May 2023
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ZA, Jinnah Postgraduate Medical Centre
- Investigators
- Zeeshan Ali, FCPS, Principal investigator, Jinnah Postgraduate Medical Centre Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895240
- Sponsor's protocol ID
- NO.F.2-81/2022-GENL/229/JPMC
- Acronym
- MUNI-SEP
- Status last verified
- May 2023
- First submitted
- 13 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MUNI-SEP TRIAL-The Role of Ulinastatin in Preventing Severe Sepsis and Consequent Morbidities and Mortality; A Randomized Clinical Trial in Pakistan.
- ClinicalTrials.gov ID
- NCT05895240
- Acronym / sponsor ID
- MUNI-SEP / NO.F.2-81/2022-GENL/229/JPMC
- Conditions
- Severe Sepsis, Septic Shock, MODS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 1 May 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 8 Jun 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.
The study will enhance the theory in the frame of reference on the efficacy of Ulinastatin while managing sepsis and subsequent morbidity and mortality. Moreover, the present study will explore Ulinastatin's prophylactic role in progression of multiple organ dysfunctions. Furthermore, the study will have the clinical implications in predicting the ICU admitted patient's stay and related cost in the context of new drug. Current researches will explore the new dimensions in Pakistan's healthcare facilities, paving the way of future academics to analyze it in order to enhance healthcare outcomes.
Detailed description
The current study is a randomised clinical trial with the aim of exploring the following objectives in the context of Pakistan:
- To determine the efficacy of Ulinastatin in preventing the progression of Sepsis to Severe Sepsis and septic shock.
- To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients.
- To investigate the impact of Ulinastatin on sepsis associated mortality and morbidity.
- To explore the role of Ulinastatin in reducing ICU stays and associated costs in defined patients.
- To provides a condensed basis to understand ULINASTATIN as a sepsis management drug.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group Arm | No intervention | –Standard of care treatment arm, study medication will not be given |
| Active Intervention Arm | Experimental | Drug: UlinastatinThis group will receive Nine MiU Ulinastatin in three divided doses 8 hourly |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age >18 or <60
- Sepsis, and severe sepsis, as defined in operational definitions
- Patients voluntarily agreed to participate in the study after informed consent
Key exclusion criteria (8 listed)
- Fulminant hepatic failure
- Acute cerebrovascular accidents
- Acute poisoning
- Chronic Kidney Disease stage 5
- Diagnosed case of immune thrombocytopenia
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 |
|---|---|---|
| UlinastatinNine MiU Ulinastatin in three divided doses 8 hourly for 3-5 days | Drug | Active Intervention Arm |
Primary outcome
Prevention of MOD's in patients with sepsis
Time frame: Day 1 of enrollment
To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients. Sepsis is defnied as evidence of infection (positive culture of blood, Urine, Tracheal) or suspected infection (by a physician) plus 2 out of 4 criteria's of SIRS. MODS is presence of two or more organ dysfunction with scoring ≥2 of each organ as per Sequential Organ Failure Assessment (SOFA) score.
Prevention of MOD's in patients with sepsis
Time frame: Day 3 of enrollment
To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients. Sepsis is defnied as evidence of infection (positive culture of blood, Urine, Tracheal) or suspected infection (by a physician) plus 2 out of 4 criteria's of SIRS. MODS is presence of two or more organ dysfunction with scoring ≥2 of each organ as per Sequential Organ Failure Assessment (SOFA) score.
Prevention of MOD's in patients with sepsis
Time frame: Day 5 of enrollment
To assess the role of Ulinastatin in preventing the onset of MODS in sepsis-induced patients. Sepsis is defnied as evidence of infection (positive culture of blood, Urine, Tracheal) or suspected infection (by a physician) plus 2 out of 4 criteria's of SIRS. MODS is presence of two or more organ dysfunction with scoring ≥2 of each organ as per Sequential Organ Failure Assessment (SOFA) score.
Effect on in-hospital mortality
Time frame: During first 48 hours of hospital stay after enrollment
To investigate the impact of Ulinastatin on sepsis associated mortality.
Effect on 7 days mortality
Time frame: During the 7 days of enrollment
To investigate the impact of Ulinastatin on sepsis associated mortality.
Effect on 14 days mortality
Time frame: During the 14 days of enrollment
To investigate the impact of Ulinastatin on sepsis associated mortality.
Effect on 28 days mortality
Time frame: During the 28 days of enrollment
To investigate the impact of Ulinastatin on sepsis associated mortality.
4 secondary outcomes
Number of days on mechanical ventilation
Time frame: Up to 28 days after enrollment
Number of days in ICU
Time frame: Up to 28 days after enrollment
Prevention of Severe Sepsis in patients admitted with Sepsis
Time frame: Up to 28 days after enrollment
Prevention of Septic Shock in patients admitted with Sepsis
Time frame: Up to 28 days after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 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.
Zeeshan Ali, FCPS principal investigator
Jinnah Postgraduate Medical Centre Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ulinastatin in people with Severe Sepsis and Septic Shock, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
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 3 inclusion and 8 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 8 Jun 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 Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zeeshan Ali, FCPS (+923211000393, dr.zeeshan.j@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of MOD's in patients with sepsis (time frame: Day 1 of enrollment). The study lists 7 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 8 Jun 2023.