Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.

NCT02588716 | Completed Phase 2

• 1 other identifier: Terlipressin
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effects of Terlipressin infusion on blood loss \& transfusion requirements in cirrhotic patients undergoing major liver resections.

Conditions

Hepatectomy, Surgical Blood Loss, Terlipressin

Keywords

Hepatectomy, Surgical Blood Loss, terlipressin

Outcome Measures

Primary Outcomes (1)

• blood loss

  blood loss in ml

  intraoperative period

Secondary Outcomes (2)

• blood units transfused

  intraoperative period

• lactate level

  at start and end of resection

Study Arms (2)

Terlipressin

ACTIVE COMPARATOR

Terlipressin will be given at the beginning of surgery as an initial bolus dose of (1 mg over 30 mins) followed by a continuous infusion of 2μg/kg/h to be continued throughout the surgery then gradually withdrawn over 4 hours

Drug: Terlipressin

Control

PLACEBO COMPARATOR

same volumes of normal saline with the same rate of infusion, throughout the operation then gradually withdrawn over 4 hours.

Drug: normal saline

Interventions

Terlipressin DRUG

Terlipressin will be given as an intravenous injection of 2μg/kg/h to be continued throughout the surgery and weaned off over four hours postoperatively.

Also known as: glipressin

Terlipressin

normal saline DRUG

Same volumes of normal saline infusion, throughout the operation then gradually withdrawn over 4 hours.

Control

Eligibility Criteria

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

You may qualify if:

• All patients older than 18 years of age, American Society of Anesthesiology (ASA) classification class I and II and assigned for elective resection of 2 or more liver segments portal hypertension

You may not qualify if:

• Patients with Child-Turcotte-Pugh grade B or C, clinically significant portal hypertension (splenomegaly, thrombocytopenia with platelets \< 1011/L, esophageal varices grade 2 or more), Preoperative renal failure (GFR \< 50ml/min), heart failure, Bradyarrhythmia (heart rate \< 60/min), history of hemorrhagic stroke, Uncontrolled arterial hypertension (Blood pressure \>160/100mmHg), and Pregnancy

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

Location

Related Publications (1)

• Abbas MS, Mohamed KS, Ibraheim OA, Taha AM, Ibraheem TM, Fadel BA, Elawamy A, Abbas AM. Effects of terlipressin infusion on blood loss and transfusion needs during liver resection: A randomised trial. Acta Anaesthesiol Scand. 2019 Jan;63(1):34-39. doi: 10.1111/aas.13226. Epub 2018 Aug 5.

  PMID: 30079635 DERIVED

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Terlipressin; Saline Solution

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, of Anesthesia & ICU, Assiut University

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 28, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 27, 2017

Record last verified: 2015-07

Locations

EG (1)