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NCT Number: NCT03395574

Effect of Terlipressin on Cerebral Oxygen Saturation During Liver Transplantation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kasr Alainy Hospital , Faculty of Medicine

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terlipressin

Drug

drug will be given after 30 minutes of induction of anesthesia

normal saline

Drug

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

Primary outcomes

  1. 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

  1. 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

  2. resistive index of middle cerebral artery

    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

    assessed by trans cranial Doppler

  3. peak velocity, end diastolic velocity of middle cerebral arteries

    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

    assessed by trans cranial Doppler

  4. End diastolic velocity of middle cerebral arteries

    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

    assessed by trans cranial Doppler

  5. 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

  6. Systolic blood pressure

    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

  7. Diastolic blood pressure

    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

  8. PH

    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

    assessed by arterial blood gases

  9. PCo2

    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

    assessed by arterial blood gases

  10. Po2

    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

    assessed by arterial blood gases

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

Effect of Terlipressin on Cerebral Oxygen Saturation and Cerebral Blood Flow During Living Donor Liver Transplantation

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 10, 2018
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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