Effect of Terlipressin on Cerebral Oxygen Saturation During Liver Transplantation

Phase 2

Completed

• Conditions: Terlipressin Adverse Reaction; Liver Transplantation
• Interventions: Drug: Terlipressin; Drug: Normal saline

• Registration Number: NCT03395574
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2017-12-25
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-10
• Study Start: 2018-01-25
• Primary Completion: 2018-11-25
• Study Completion: 2018-11-25
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
terlipressin group	Terlipressin	group will receive terlipressin infusion one mg in 50 ml normal saline will be given over 30 minute as loading dose then will be maintained as infusion of 160 μg per hour (8 ml/h).
saline (control) group	Normal saline	group will receive normal saline infusion 50 ml normal saline will be given over 30 minute as loading dose then will be maintained as infusion of (8 ml/h).

Primary Outcome Measures

Name	Time	Method
cerebral oxygen saturation	one hour after infusion of drug	regional oxygen saturation assessed by cerebral oxymetry with probes applied on forehead

Secondary Outcome Measures

Name	Time	Method
cerebral oxygen saturation	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	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	assessed by trans cranial Doppler
peak velocity, end diastolic velocity of middle cerebral arteries	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	assessed by trans cranial Doppler
End diastolic velocity of middle cerebral arteries	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	assessed by trans cranial Doppler
Heart rate	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
Systolic blood pressure	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
Diastolic blood pressure	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
PH	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	assessed by arterial blood gases
PCo2	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	assessed by arterial blood gases
Po2	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	assessed by arterial blood gases

Trial Locations

Locations (1)

Kasr Alainy Hospital , Faculty of Medicine; 🇪🇬 Cairo, Egypt