Resolution of Septic Shock With TerlipressinPhase 2/3NCT03608514
Terlipressin Alone Versus the Standard Therapy With Catecholamines for Hepatic Patients With Septic Shock- Prospective Single Center Randomized Controlled Study.
A Phase 2/3 study testing Experimental in people with Resolution of Septic Shock With Terlipressin, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate the use of terlipressin compared to standard regimen in hepatic patients with septic shock. Another aim is to compare the mortality rate \& the effects on renal functions in both groups. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Resolution of Septic Shock With Terlipressin
- What is being tested?
- Experimental
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to Dec 2020
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 18 \& 70years who will be admitted to the intensive care unit (ICU) of National Hepatology \& Tropical Medicine Research Institute (NHTMRI).
- All patients that will be included in the study should have septic shock diagnosed by having sepsis with an underlying circulatory and cellular/metabolic abnormality.
Who cannot join
- Patients will be excluded if they are pregnant, have uncontrolled hypertension, ischemic skin necrosis, present or suspected coronary artery disease, present or suspected acute mesenteric ischemia, or peripheral vascular diseases (e.g. Raynaud's syndrome or related diseases) and hypersensitivity to Terlipressin.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
NHTMRI
Cairo, 11441
Eman El-Desoki, Ph D, 01227409501, eman18350@gmail.com
About this study
The purpose of this study is to evaluate the use of terlipressin compared to standard regimen in hepatic patients with septic shock. Another aim is to compare the mortality rate \& the effects on renal functions in both groups.
Read the detailed description
Study type:
This is a single center, prospective randomized controlled study.
Inclusion criteria:
The subjects are adults aged between 18 \& 70 years who will be admitted to the intensive care unit (ICU) of National Hepatology \& Tropical Medicine Research Institute (NHTMRI).
All patients that will be included in the study should have septic shock diagnosed by having sepsis with an underlying circulatory and cellular/metabolic abnormality
Exclusion criteria:
Patients will be excluded if they are pregnant, have uncontrolled hypertension, ischemic skin necrosis, present or suspected coronary artery disease, present or suspected acute mesenteric ischemia, or peripheral vascular diseases (e.g. Raynaud's syndrome or related diseases) or hypersensitivity to terlipressin.
Study design:
Fifty patients will be enrolled in each arm of the study \& randomly assigned in a 1:1 manner to receive either intravenous infusion (IVi) terlipressin by rate 1-2µg/kg/min. or intravenous infusion norepinephrine in an initial dose of 0.01µg/kg/min which can be increased every 15-30min. to 3µg/kg/min. maximum ± epinephrine with an initial dose 0.05µg/kg/min. IVi \& can be titrated every 15-30min. The increments of epinephrine dose will be 0.05- 0.2µg/kg/min. and up to 2µg/Kg/min. The end point of the study will be achieving mean arterial pressure ≥ 65mmHg \& normalized lactate ≤ 2mmol/L or lactate clearance ≥ 10% within 6hours All demographic data will be obtained at time of admission, including the patients' age, sex, body mass index (BMI), associated co-morbidities (diabetes mellitus, hypertension), Child-Pugh score and Sequential Organ Failure Assessment (SOFA).
Vital signs including the heart rate, mean arterial pressure (MAP) through arterial cannula, central venous pressure (CVP) through a catheter inserted either in the internal jugular vein or the subclavian vein will be measured at admission and at regular intervals. The volume \& fluid balance will be recorded at admission and then will be followed up daily and recorded as required. Daily ECG with ST analysis, lactate level \& ScVO2 will be measured on admission and then recorded at regular intervals during treatment after 2, 6, 12, 24 \& 48hours.
Organ dysfunction and injury (aspartate aminotransferase, alanine amino-transaminase, total bilirubin, international normalized ratio, serum creatinine and troponin-I) will be analyzed at admission, and after 12, 24 \& 48hours of treatment.
The rate of norepinephrine ± epinephrine infusion as well as terlipressin dose required to keep MAP at 65 mmHg will be recorded at baseline and 6, 12, 24, and 48hours after treatment.
Twenty-eight day mortality will be followed by phone calls to the patient or one of his/her first-degree relatives.
- Being tested
- Experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDrug
Also called Terlipressin intravenous infusion
Patients in this arm of the study will receive intravenous infusion (IVi) terlipressin by rate 1-2µg/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| nor-epinephrine+/- epinephrine infusion | Active comparator | Intravenous infusion of Nor-epinephrine in an initial dose of 0.01µg/kg/min. which can be increased every 15-30 minutes to maximum 3µg/kg/min. ± intravenous infusion of epinephrine with an initial dose 0.05µg/kg/min. \& can be titrated every 15-30 minutes up to 2µg/Kg/min.
The end point is to achieve mean arterial pressure ≥ 65 mmHg \& normalized lactate ≤ 2 mmol/L or lactate clearance ≥ 10% within 6 hours.
Patients will be followed for 48 hours. Receives: Drug: Experimental |
| Terlipressin infusion | Other | Intravenous infusion of terlipressin by rate 1-2µg/kg/min. The end point is to achieve mean arterial pressure ≥ 65 mmHg \& normalized lactate ≤ 2mmol/L or lactate clearance ≥ 10% within 6 hours.
Patients will be followed for 48 hours. Receives: Drug: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic stability & optimization; mean blood pressure more than or equal 65mmHg
how fast hemodynamic stability will be achieved in each arm of the study
Measured: 48hours up to 7days
mortality
28-day mortality will be followed by phone calls to the patient or one of his/her first degree relatives
Measured: 28 days
Hemodynamic stability & optimization; mean blood pressure
for how long hemodynamic stability will be maintained
Measured: 48hours up to 7days
Hemodynamic stability & optimization, lactate clearance to be 2mmol/L
how fast it will be achieved
Measured: 48hours up to 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Jul 2018
- Primary completionJul 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resolution of Septic Shock With TerlipressinStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Fifty patients will be enrolled in each arm of the study \& randomly assigned in a 1:1 manner to receive either terlipressin alone versus the standard therapy (norepinephrine +/- epinephrine).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Hepatology & Tropical Medicine Research Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eman Desoki, National Hepatology & Tropical Medicine Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608514
- Sponsor's protocol ID
- NHTMRI-ICU-B
- Status last verified
- Aug 2018
- First submitted
- 12 Jul 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terlipressin Alone Versus the Standard Therapy With Catecholamines for Hepatic Patients With Septic Shock- Prospective Single Center Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT03608514
- Acronym / sponsor ID
- NHTMRI-ICU-B
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Hepatology & Tropical Medicine Research InstituteOther government
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Aug 2018 (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 purpose of this study is to evaluate the use of terlipressin compared to standard regimen in hepatic patients with septic shock. Another aim is to compare the mortality rate \& the effects on renal functions in both groups.
Detailed description
Study type:
This is a single center, prospective randomized controlled study.
Inclusion criteria:
The subjects are adults aged between 18 \& 70 years who will be admitted to the intensive care unit (ICU) of National Hepatology \& Tropical Medicine Research Institute (NHTMRI).
All patients that will be included in the study should have septic shock diagnosed by having sepsis with an underlying circulatory and cellular/metabolic abnormality
Exclusion criteria:
Patients will be excluded if they are pregnant, have uncontrolled hypertension, ischemic skin necrosis, present or suspected coronary artery disease, present or suspected acute mesenteric ischemia, or peripheral vascular diseases (e.g. Raynaud's syndrome or related diseases) or hypersensitivity to terlipressin.
Study design:
Fifty patients will be enrolled in each arm of the study \& randomly assigned in a 1:1 manner to receive either intravenous infusion (IVi) terlipressin by rate 1-2µg/kg/min. or intravenous infusion norepinephrine in an initial dose of 0.01µg/kg/min which can be increased every 15-30min. to 3µg/kg/min. maximum ± epinephrine with an initial dose 0.05µg/kg/min. IVi \& can be titrated every 15-30min. The increments of epinephrine dose will be 0.05- 0.2µg/kg/min. and up to 2µg/Kg/min. The end point of the study will be achieving mean arterial pressure ≥ 65mmHg \& normalized lactate ≤ 2mmol/L or lactate clearance ≥ 10% within 6hours All demographic data will be obtained at time of admission, including the patients' age, sex, body mass index (BMI), associated co-morbidities (diabetes mellitus, hypertension), Child-Pugh score and Sequential Organ Failure Assessment (SOFA).
Vital signs including the heart rate, mean arterial pressure (MAP) through arterial cannula, central venous pressure (CVP) through a catheter inserted either in the internal jugular vein or the subclavian vein will be measured at admission and at regular intervals. The volume \& fluid balance will be recorded at admission and then will be followed up daily and recorded as required. Daily ECG with ST analysis, lactate level \& ScVO2 will be measured on admission and then recorded at regular intervals during treatment after 2, 6, 12, 24 \& 48hours.
Organ dysfunction and injury (aspartate aminotransferase, alanine amino-transaminase, total bilirubin, international normalized ratio, serum creatinine and troponin-I) will be analyzed at admission, and after 12, 24 \& 48hours of treatment.
The rate of norepinephrine ± epinephrine infusion as well as terlipressin dose required to keep MAP at 65 mmHg will be recorded at baseline and 6, 12, 24, and 48hours after treatment.
Twenty-eight day mortality will be followed by phone calls to the patient or one of his/her first-degree relatives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Fifty patients will be enrolled in each arm of the study \& randomly assigned in a 1:1 manner to receive either terlipressin alone versus the standard therapy (norepinephrine +/- epinephrine).
| Arm | Type | Receives |
|---|---|---|
| nor-epinephrine+/- epinephrine infusion | Active comparator | Drug: ExperimentalIntravenous infusion of Nor-epinephrine in an initial dose of 0.01µg/kg/min. which can be increased every 15-30 minutes to maximum 3µg/kg/min. ± intravenous infusion of epinephrine with an initial dose 0.05µg/kg/min. \& can be titrated every 15-30 minutes up to 2µg/Kg/min. The end point is to achieve mean arterial pressure ≥ 65 mmHg \& normalized lactate ≤ 2 mmol/L or lactate clearance ≥ 10% within 6 hours. Patients will be followed for 48 hours. |
| Terlipressin infusion | Other | Drug: ExperimentalIntravenous infusion of terlipressin by rate 1-2µg/kg/min. The end point is to achieve mean arterial pressure ≥ 65 mmHg \& normalized lactate ≤ 2mmol/L or lactate clearance ≥ 10% within 6 hours. Patients will be followed for 48 hours. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged between 18 \& 70years who will be admitted to the intensive care unit (ICU) of National Hepatology \& Tropical Medicine Research Institute (NHTMRI).
- All patients that will be included in the study should have septic shock diagnosed by having sepsis with an underlying circulatory and cellular/metabolic abnormality.
Key exclusion criteria (1 listed)
- Patients will be excluded if they are pregnant, have uncontrolled hypertension, ischemic skin necrosis, present or suspected coronary artery disease, present or suspected acute mesenteric ischemia, or peripheral vascular diseases (e.g. Raynaud's syndrome or related diseases) and hypersensitivity to Terlipressin.
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 |
|---|---|---|
| ExperimentalAlso: Terlipressin intravenous infusionPatients in this arm of the study will receive intravenous infusion (IVi) terlipressin by rate 1-2µg/kg/min. | Drug | Terlipressin infusion, nor-epinephrine+/- epinephrine infusion |
Primary outcome
Hemodynamic stability & optimization; mean blood pressure more than or equal 65mmHg
Time frame: 48hours up to 7days
how fast hemodynamic stability will be achieved in each arm of the study
mortality
Time frame: 28 days
28-day mortality will be followed by phone calls to the patient or one of his/her first degree relatives
Hemodynamic stability & optimization; mean blood pressure
Time frame: 48hours up to 7days
for how long hemodynamic stability will be maintained
Hemodynamic stability & optimization, lactate clearance to be 2mmol/L
Time frame: 48hours up to 7days
how fast it will be achieved
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Individual participant dataSharing planned: Yes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Experimental in people with Resolution of Septic Shock With Terlipressin, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
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 1 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 6 Aug 2018. 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 Egypt. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic stability & optimization; mean blood pressure more than or equal 65mmHg (time frame: 48hours up to 7days). The study lists 4 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 6 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.