CirrhosisNCT03145168
High Versus Low Target Mean Arterial Pressure in Septic Shock in Critically Ill Cirrhotics
A study testing High Target Mean Arterial Pressure and Low Target Mean Arterial Pressure in people with Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Study Design: A randomized controlled study. The study will be conducted on patients admitted to Department of Hepatology from April 2017 to October 2017 at ILBS, New Delhi Study group will comprise of patients critically ill cirrhotics with septic shock All included patients would be randomised to low target MAP… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- High Target Mean Arterial Pressure and Low Target Mean Arterial Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 19 Sep 2018to 18 Mar 2021
- 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
Who may be able to join
- Critically ill cirrhotics with septic shock
Who cannot join
- Patients with age less than 18 years
- Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)
- Pregnancy
- Chronic kidney disease on hemodialysis
- Extremely moribund patients with an expected life expectancy of less than 24 hours
- Failure to give informed consent from family members.
- Hemodynamic instability requiring very high dose of vasopressors
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: High Versus Low Target Mean Arterial Pressure in Septic Shock in Critically Ill Cirrhotics -A Randomized Controlled Trial
Study Design:
- A randomized controlled study.
- The study will be conducted on patients admitted to Department of Hepatology from April 2017 to October 2017 at ILBS, New Delhi
- Study group will comprise of patients critically ill cirrhotics with septic shock
Read more
All included patients would be randomised to low target MAP group (60-65mm Hg) or high target group (80-85 mm of Hg). Patients older than 18 years of age will be enrolled if they have septic shock that is refractory to fluid resuscitation and if they required vasopressors (norepinephrine or epinephrine or terlipressin) at a minimum infusion rate of 0.1 μg per kilogram per minute. Standard criteria will be considered to define refractoriness to fluids. The target MAP would be maintained for a max. of 5 days or until recovery or shock and or AKI. In the high-target group, a reduction in vasopressor doses to maintain a mean arterial pressure of 65 to 70 mm Hg will be done in case of any of the prespecified serious adverse events that could potentially be related to an increased rate of vasopressor infusion occurred. These events could be: clinically relevant bleeding (i.e., transfusion requirements of at least 2 units of packed red cells), myocardial infarction (defined as typical electrocardiographic changes, with a concomitant increase in troponin, and segmental echocardiographic hypokinesia or akinesia, with the infarction confirmed, when possible, by means of coronary angiography), major ventricular arrhythmia, poorly tolerated supraventricular arrhythmia, mesenteric ischemia, and distal-limb ischemia.
- Septic shock would be defined as clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP>=65 mm of Hg and having a serum lactate >2 mmol/L despite adequate volume resuscitation
- Conditions
- Cirrhosis
- Being tested
- High Target Mean Arterial Pressure, Low Target Mean Arterial Pressure
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Target Mean Arterial PressureOther
High target group (80-85 mm of Hg).
Low Target Mean Arterial PressureOther
Low target MAP group (60-65mm Hg).
| Study group | Role | What they receive |
|---|---|---|
| High Target Mean Arterial Pressure | Experimental | Not described Receives: Other: High Target Mean Arterial Pressure |
| Low target Mean Arterial Pressure | Active comparator | Not described Receives: Other: Low Target Mean Arterial Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival in both groups
Measured: 28 days
Secondary outcomes (5)
Duration of mechanical ventilation
Measured: 3 months
Incidence of intradialytic hypotension in patients undergoing Renal Replacement Therapy
Measured: 3 months
Duration of Intensive Care Unit /Hospital stay
Measured: 3 months
Reversal of shock in both groups
Measured: Day 5
Acute Kidney Injury in both groups.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start19 Sep 2018
- Primary completion18 Mar 2021
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145168
- Sponsor's protocol ID
- ILBS-Cirrhosis-08
- Status last verified
- Sep 2022
- First submitted
- 10 Apr 2017
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maiwall R, Rao Pasupuleti SS, Hidam AK, Kumar A, Tevethia HV, Vijayaraghavan R, Majumdar A, Prasher A, Thomas S, Mathur RP, Kumar G, Sarin SK. A randomised-controlled trial (TARGET-C) of high vs. low target mean arterial pressure in patients with cirrhosis and septic shock. J Hepatol. 2023 Aug;79(2):349-361. doi: 10.1016/j.jhep.2023.04.006. Epub 2023 Apr 23.
PubMed 37088310
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Versus Low Target Mean Arterial Pressure in Septic Shock in Critically Ill Cirrhotics -A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03145168
- Acronym / sponsor ID
- ILBS-Cirrhosis-08
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 9 May 2017 (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.
Study Design:
- A randomized controlled study.
- The study will be conducted on patients admitted to Department of Hepatology from April 2017 to October 2017 at ILBS, New Delhi
- Study group will comprise of patients critically ill cirrhotics with septic shock
All included patients would be randomised to low target MAP group (60-65mm Hg) or high target group (80-85 mm of Hg). Patients older than 18 years of age will be enrolled if they have septic shock that is refractory to fluid resuscitation and if they required vasopressors (norepinephrine or epinephrine or terlipressin) at a minimum infusion rate of 0.1 μg per kilogram per minute. Standard criteria will be considered to define refractoriness to fluids. The target MAP would be maintained for a max. of 5 days or until recovery or shock and or AKI. In the high-target group, a reduction in vasopressor doses to maintain a mean arterial pressure of 65 to 70 mm Hg will be done in case of any of the prespecified serious adverse events that could potentially be related to an increased rate of vasopressor infusion occurred. These events could be: clinically relevant bleeding (i.e., transfusion requirements of at least 2 units of packed red cells), myocardial infarction (defined as typical electrocardiographic changes, with a concomitant increase in troponin, and segmental echocardiographic hypokinesia or akinesia, with the infarction confirmed, when possible, by means of coronary angiography), major ventricular arrhythmia, poorly tolerated supraventricular arrhythmia, mesenteric ischemia, and distal-limb ischemia.
- Septic shock would be defined as clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP>=65 mm of Hg and having a serum lactate >2 mmol/L despite adequate volume resuscitation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Target Mean Arterial Pressure | Experimental | Other: High Target Mean Arterial Pressure |
| Low target Mean Arterial Pressure | Active comparator | Other: Low Target Mean Arterial Pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Critically ill cirrhotics with septic shock
Key exclusion criteria (7 listed)
- Patients with age less than 18 years
- Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)
- Pregnancy
- Chronic kidney disease on hemodialysis
- Extremely moribund patients with an expected life expectancy of less than 24 hours
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 |
|---|---|---|
| High Target Mean Arterial PressureHigh target group (80-85 mm of Hg). | Other | High Target Mean Arterial Pressure |
| Low Target Mean Arterial PressureLow target MAP group (60-65mm Hg). | Other | Low target Mean Arterial Pressure |
Primary outcome
Survival in both groups
Time frame: 28 days
5 secondary outcomes
Duration of mechanical ventilation
Time frame: 3 months
Incidence of intradialytic hypotension in patients undergoing Renal Replacement Therapy
Time frame: 3 months
Duration of Intensive Care Unit /Hospital stay
Time frame: 3 months
Reversal of shock in both groups
Time frame: Day 5
Acute Kidney Injury in both groups.
Time frame: Day 5
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 21 Sep 2022.
- Derived from this study: PubMed 37088310Maiwall R, Rao Pasupuleti SS, Hidam AK, Kumar A, Tevethia HV, Vijayaraghavan R, Majumdar A, Prasher A, Thomas S, Mathur RP, Kumar G, Sarin SK. A randomised-controlled trial (TARGET-C) of high vs. low target mean arterial pressure in patients with cirrhosis and septic shock. J Hepatol. 2023 Aug;79(2):349-361. doi: 10.1016/j.jhep.2023.04.006. Epub 2023 Apr 23.
- 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.
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 High Target Mean Arterial Pressure and Low Target Mean Arterial Pressure in people with Cirrhosis, run by Institute of Liver and Biliary Sciences, India 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 7 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 21 Sep 2022. 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?
Survival in both groups (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03145168, which also lists 1 linked publication.
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 21 Sep 2022.