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

Primary Purpose

Resolution of Septic Shock With Terlipressin

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Experimental
Sponsored by
National Hepatology & Tropical Medicine Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resolution of Septic Shock With Terlipressin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NHTMRIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

nor-epinephrine+/- epinephrine infusion

Terlipressin infusion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hemodynamic stability & optimization; mean blood pressure more than or equal 65mmHg
how fast hemodynamic stability will be achieved in each arm of the study
mortality
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
for how long hemodynamic stability will be maintained
Hemodynamic stability & optimization, lactate clearance to be 2mmol/L
how fast it will be achieved

Secondary Outcome Measures

Full Information

First Posted
July 12, 2018
Last Updated
August 2, 2018
Sponsor
National Hepatology & Tropical Medicine Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03608514
Brief Title
Terlipressin Alone Versus the Standard Therapy With Catecholamines for Hepatic Patients With Septic Shock- Prospective Single Center Randomized Controlled Study.
Official Title
Terlipressin Alone Versus the Standard Therapy With Catecholamines for Hepatic Patients With Septic Shock- Prospective Single Center Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Hepatology & Tropical Medicine Research Institute

4. Oversight

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

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resolution of Septic Shock With Terlipressin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
patients will be randomly assigned in 1:1 manner
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nor-epinephrine+/- epinephrine infusion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Terlipressin infusion
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Experimental
Other Intervention Name(s)
Terlipressin intravenous infusion
Intervention Description
Patients in this arm of the study will receive intravenous infusion (IVi) terlipressin by rate 1-2µg/kg/min.
Primary Outcome Measure Information:
Title
Hemodynamic stability & optimization; mean blood pressure more than or equal 65mmHg
Description
how fast hemodynamic stability will be achieved in each arm of the study
Time Frame
48hours up to 7days
Title
mortality
Description
28-day mortality will be followed by phone calls to the patient or one of his/her first degree relatives
Time Frame
28 days
Title
Hemodynamic stability & optimization; mean blood pressure
Description
for how long hemodynamic stability will be maintained
Time Frame
48hours up to 7days
Title
Hemodynamic stability & optimization, lactate clearance to be 2mmol/L
Description
how fast it will be achieved
Time Frame
48hours up to 7days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
NHTMRI
City
Cairo
ZIP/Postal Code
11441
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman El-Desoki, Ph D
Phone
01227409501
Email
eman18350@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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