NCT03395574 - Effect of Terlipressin on Cerebral Oxygen Saturation During Liver Transplantation | Crick

Overview

in our study the investigators aim to assess the effect of terlipressin on cerebral oxygenation monitored by cerebral oxymetry and cerebral blood flow measured by transcranial doppler.

All patients will receive 6ml /kg/h Ringer acetate solution as a maintenance intraoperative fluid. If pulse pressure variations (PPV) is more than 15%, the patient will be considered as fluid responder and will receive a 250-ml bolus of albumin 5% to maintain PPV ≤15%. Blood transfusion will be given based on a hemoglobin level (\< 7 g/dl) in both (control group) and (terlipressin group). Other blood products will be transfused guided by lab result; Fresh frozen plasma will be given when INR \> 2 and platelets will be given when platelets \<30.000/mm3. The patients will be randomly allocated into 2 groups; Group T (Terlipressin group) and group S (Normal saline 0.9%). For (terlipressin group) all patients will receive loading dose of terlipressin (1mg diluted with 50 ml of normal saline 0.9% solution over 30 min) and it will be maintained by continuous infusion at rate of 160 μg per hour (8 ml/h). For (control group) all patient will receive 50 ml of normal saline 0.9% solution over 30 min and will be maintained continuous infusion at rate of 8 ml/h. Drugs will be prepared by the nurse and the investigator will be blinded to the drug given.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

30

Conditions

Terlipressin Adverse Reaction Liver Transplantation

Interventions

TerlipressinDRUG

drug will be given after 30 minutes of induction of anesthesia

Normal salineDRUG

drug will be given after 30 minutes as placebo in control group

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ASA II-IV undergoing orthotopic liver transplantation. * Age above 18 years. Exclusion Criteria: * Age below 18 years. * Patients on Terlipressin preoperative. * Patients known allergic to Terlipressin. * Portal vein thrombosis. * Ischemic heart disease. * Patients with T. bilirubin level above 7 mg/dl

Locations (1)

Kasr Alainy Hospital , Faculty of Medicine

Cairo, Egypt

Outcomes

Primary Outcomes

cerebral oxygen saturation

regional oxygen saturation assessed by cerebral oxymetry with probes applied on forehead

Time frame: one hour after infusion of drug

Secondary Outcomes

cerebral oxygen saturation

regional oxygen saturation assessed by cerebral oxymetry with probes applied on forehead

Time frame: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion

resistive index of middle cerebral artery

assessed by trans cranial Doppler

Time frame: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion

peak velocity, end diastolic velocity of middle cerebral arteries

assessed by trans cranial Doppler

Time frame: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion

End diastolic velocity of middle cerebral arteries

assessed by trans cranial Doppler

Time frame: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion

Heart rate

Time frame: baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion