Effect of Terlipressin on Cerebral Oxygen Saturation During Liver Transplantation

NCT03395574 | Completed Phase 2

• 1 other identifier: N-113-2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Terlipressin Adverse Reaction; Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• cerebral oxygen saturation

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

  one hour after infusion of drug

Secondary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

terlipressin group

EXPERIMENTAL

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

saline (control) group

PLACEBO COMPARATOR

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

Interventions

Terlipressin DRUG

drug will be given after 30 minutes of induction of anesthesia

terlipressin group

Normal saline DRUG

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

saline (control) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA II-IV undergoing orthotopic liver transplantation.
• Age above 18 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy Hospital , Faculty of Medicine

Cairo, Egypt

Location

Related Publications (5)

• 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.

  PMID: 19127448 BACKGROUND

• 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.

  PMID: 20008083 BACKGROUND

• 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.

  PMID: 20508990 BACKGROUND

• 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.

  PMID: 22104067 BACKGROUND

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

  PMID: 10840602 BACKGROUND

MeSH Terms

Interventions

Terlipressin; Saline Solution

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• ahmed mohamed mokhtar, M.D

  kasralainy faculty of medicine, Cairo university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Study Record Dates

• First Submitted: December 25, 2017
• First Posted: January 10, 2018
• Study Start: January 25, 2018
• Primary Completion: November 25, 2018
• Study Completion: November 25, 2018
• Last Updated: December 24, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)