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

NCT03608514 | Unknown Phase 2 FDA Drug

• 1 other identifier: NHTMRI-ICU-B
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Resolution of Septic Shock With Terlipressin

Outcome Measures

Primary Outcomes (4)

• Hemodynamic stability & optimization; mean blood pressure more than or equal 65mmHg

  how fast hemodynamic stability will be achieved in each arm of the study

  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

  28 days

• Hemodynamic stability & optimization; mean blood pressure

  for how long hemodynamic stability will be maintained

  48hours up to 7days

• Hemodynamic stability & optimization, lactate clearance to be 2mmol/L

  how fast it will be achieved

  48hours up to 7days

Study Arms (2)

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.

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.

Drug: Experimental

Interventions

Experimental DRUG

Patients in this arm of the study will receive intravenous infusion (IVi) terlipressin by rate 1-2µg/kg/min.

Also known as: Terlipressin intravenous infusion

Terlipressin infusion; nor-epinephrine+/- epinephrine infusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Hepatology & Tropical Medicine Research Institute: lead

Study Sites (1)

NHTMRI

Cairo, 11441, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients will be randomly assigned in 1:1 manner
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow of intensive care medicine, NHTMRI

Model Details: 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).

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: August 1, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 6, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)