Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery

NCT02718599 | Completed Phase 2 DMC

• 1 other identifier: ABC-123-DE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of terlipressin infusion on systemic and hepatic hemodynamics during hepatobiliary surgery

Conditions

Hemodynamics, Liver, Terlipressin

Outcome Measures

Primary Outcomes (1)

• portal pressure changes

  portal pressure changes in mmHg

  intraoperative period

Secondary Outcomes (3)

• Effect on systemic vascular resistance

  intraoperative period

• Renal impairment

  for 3 days in the postoperative period

• Blood units transfused

  intraoperative period

Study Arms (2)

Terlipressin

ACTIVE COMPARATOR

Terlipressin will be started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours.

Drug: terlipressin

CONTROL

PLACEBO COMPARATOR

Patients receive the same volume of 0.9% saline in place of terlipressin for the same duration(50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours).

Drug: normal saline

Interventions

terlipressin DRUG

Terlipressin will be started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours.

Also known as: glypressin

Terlipressin

normal saline DRUG

Patients receive 50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours.

Also known as: 0.9 Nacl

CONTROL

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years.
• Any gender.
• ASA (American Society of Anesthesiologists) Classification( Class I-II)
• Patients undergoing major elective hepatobiliary surgery.

You may not qualify if:

• Preoperative renal failure (GFR \< 50 ml/min).
• Severe liver dysfunction (Child- turcotte -Pugh grade C).
• Hyponatremia (\<132 mmol/l).
• Severe aortic regurgitation, severe mitral regurgitation, heart failure.
• Symptomatic coronary heart disease.
• Bradycardic arrhythmia (heart rate \< 60/min).
• Peripheral artery occlusive disease (clinical stadium II-IV).
• Uncontrolled arterial hypertension (Blood pressure \>160/100 mmHg despite intensive treatment).
• Pregnancy.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

Location

Related Publications (1)

• Mahdy MM, Abbas MS, Kamel EZ, Mostafa MF, Herdan R, Hassan SA, Hassan R, Taha AM, Ibraheem TM, Fadel BA, Geddawy M, Sayed JA, Ibraheim OA. Effects of terlipressin infusion during hepatobiliary surgery on systemic and splanchnic haemodynamics, renal function and blood loss: a double-blind, randomized clinical trial. BMC Anesthesiol. 2019 Jun 15;19(1):106. doi: 10.1186/s12871-019-0779-6.

  PMID: 31200638 DERIVED

MeSH Terms

Interventions

Terlipressin; Saline Solution; Sodium Chloride

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mostafa Samy

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effect of terlipressin and hepatic hemodynamics during hepatobiliary surgery infusion on systemic.

Study Record Dates

• First Submitted: March 19, 2016
• First Posted: March 24, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 19, 2017

Record last verified: 2016-03

Locations

EG (1)