Clinical trial NCT03608514: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Resolution of Septic Shock With Terlipressin
Lead sponsor: National Hepatology & Tropical Medicine Research Institute
Sponsor class: OTHER_GOV
First posted: 2018-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hemodynamic stability & optimization; mean blood pressure more than or equal 65mmHg
timeFrame: 48hours up to 7days
measure: mortality
timeFrame: 28 days
measure: Hemodynamic stability & optimization; mean blood pressure
timeFrame: 48hours up to 7days
measure: Hemodynamic stability & optimization, lactate clearance to be 2mmol/L
timeFrame: 48hours up to 7days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: NHTMRI
Study officials:
References: