NCT03395574·Phase 2·INTERVENTIONAL

Effect of Terlipressin on Cerebral Oxygen Saturation During Liver Transplantation

Terlipressin Other Completed

Status

Completed

Phase

Phase 2

Enrollment

30

Locations

1

Results

Not posted

Publications

5

Study summary

What the protocol is testing.

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.

Full detailed description

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.

Interventions

Treatment arms and agents.

DRUG

Terlipressin

drug will be given after 30 minutes of induction of anesthesia

DRUG

Normal saline

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

Timeline

From registration to results.

First posted
Jan 10, 2018
Study start
Jan 25, 2018
Primary completion
Nov 25, 2018
Study completion
Nov 25, 2018
Results posted
Not reported
Registry updated
Dec 24, 2018

Outcomes

What the study measures.

Primary outcomes

cerebral oxygen saturation

Time frame · one hour after infusion of drug

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

Secondary outcomes

cerebral oxygen saturation

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

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

resistive index of middle cerebral artery