Terlipressin Alone Versus the Standard Therapy With Catecholamines for Hepatic Patients With Septic Shock- Prospective Single Center Randomized Controlled Study.

August 2, 2018 updated by: Eman Desoki, National Hepatology & Tropical Medicine Research Institute
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11441
        • Recruiting
        • NHTMRI
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

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) and hypersensitivity to Terlipressin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: nor-epinephrine+/- epinephrine infusion

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.
Drug: Experimental
Patients in this arm of the study will receive intravenous infusion (IVi) terlipressin by rate 1-2µg/kg/min.
Other Names:
  • Terlipressin intravenous infusion
OTHER: Terlipressin infusion

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.
Drug: Experimental
Patients in this arm of the study will receive intravenous infusion (IVi) terlipressin by rate 1-2µg/kg/min.
Other Names:
  • Terlipressin intravenous infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
48hours up to 7days
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
28 days
Hemodynamic stability & optimization; mean blood pressure
Time Frame: 48hours up to 7days
for how long hemodynamic stability will be maintained
48hours up to 7days
Hemodynamic stability & optimization, lactate clearance to be 2mmol/L
Time Frame: 48hours up to 7days
how fast it will be achieved
48hours up to 7days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Hepatology & Tropical Medicine Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NHTMRI-ICU-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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