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Effect of Terlipressin on Cerebral Oxygen Saturation During Liver Transplantation

NCT ID: NCT03395574

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-25

Study Completion Date

2018-11-25

Brief Summary

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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

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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.

Conditions

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Terlipressin Adverse Reaction Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Terlipressin

Intervention Type DRUG

drug will be given after 30 minutes of induction of anesthesia

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).

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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Terlipressin

drug will be given after 30 minutes of induction of anesthesia

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Elayashy Mohamed Ahmed Hassan

lecturer of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmed mohamed mokhtar, M.D

Role: STUDY_DIRECTOR

kasralainy faculty of medicine, Cairo university

Locations

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Kasr Alainy Hospital , Faculty of Medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Czosnyka M, Brady K, Reinhard M, Smielewski P, Steiner LA. Monitoring of cerebrovascular autoregulation: facts, myths, and missing links. Neurocrit Care. 2009;10(3):373-86. doi: 10.1007/s12028-008-9175-7. Epub 2009 Jan 6.

Reference Type BACKGROUND
PMID: 19127448 (View on PubMed)

Joshi B, Brady K, Lee J, Easley B, Panigrahi R, Smielewski P, Czosnyka M, Hogue CW Jr. Impaired autoregulation of cerebral blood flow during rewarming from hypothermic cardiopulmonary bypass and its potential association with stroke. Anesth Analg. 2010 Feb 1;110(2):321-8. doi: 10.1213/ANE.0b013e3181c6fd12. Epub 2009 Dec 11.

Reference Type BACKGROUND
PMID: 20008083 (View on PubMed)

Dhiman RK, Kurmi R, Thumburu KK, Venkataramarao SH, Agarwal R, Duseja A, Chawla Y. Diagnosis and prognostic significance of minimal hepatic encephalopathy in patients with cirrhosis of liver. Dig Dis Sci. 2010 Aug;55(8):2381-90. doi: 10.1007/s10620-010-1249-7. Epub 2010 May 28.

Reference Type BACKGROUND
PMID: 20508990 (View on PubMed)

Joshi B, Ono M, Brown C, Brady K, Easley RB, Yenokyan G, Gottesman RF, Hogue CW. Predicting the limits of cerebral autoregulation during cardiopulmonary bypass. Anesth Analg. 2012 Mar;114(3):503-10. doi: 10.1213/ANE.0b013e31823d292a. Epub 2011 Nov 21.

Reference Type BACKGROUND
PMID: 22104067 (View on PubMed)

Bechstein WO, Neuhaus P. [Bleeding problems in liver surgery and liver transplantation]. Chirurg. 2000 Apr;71(4):363-8. doi: 10.1007/s001040051066. German.

Reference Type BACKGROUND
PMID: 10840602 (View on PubMed)

Other Identifiers

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N-113-2017

Identifier Type: -

Identifier Source: org_study_id