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Effect of Terlipressin on Cerebral Oxygen Saturation During Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395574
Recruitment Status : Completed
First Posted : January 10, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Elayashy Mohamed Ahmed Hassan, Kasr El Aini Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Terlipressin Adverse Reaction Liver Transplantation Drug: Terlipressin Drug: Normal saline Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Terlipressin on Cerebral Oxygen Saturation and Cerebral Blood Flow During Living Donor Liver Transplantation
Actual Study Start Date : January 25, 2018
Actual Primary Completion Date : November 25, 2018
Actual Study Completion Date : November 25, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: terlipressin group
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).
 Drug: Terlipressin
drug will be given after 30 minutes of induction of anesthesia
Placebo Comparator: saline (control) group
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).
 Drug: Normal saline
drug will be given after 30 minutes as placebo in control group


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395574


Locations
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Egypt
Kasr Alainy Hospital , Faculty of Medicine
Cairo, Egypt
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Study Director: ahmed mohamed mokhtar, M.D kasralainy faculty of medicine, Cairo university
More Information
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Publications:

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Responsible Party: Mohamed Elayashy Mohamed Ahmed Hassan, lecturer of anesthesia, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03395574    
Other Study ID Numbers: N-113-2017
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Terlipressin
Antihypertensive Agents
Vasoconstrictor Agents