Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs

NCT03572088 | Completed Phase 2 DMC

• 1 other identifier: ABC-223-DE
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present study aims to look at the effect of terlipressin infusion on blood loss and blood transfusion needs during Whipple procedure

Conditions

Terlipressin; Blood Loss

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood loss

  Amount of intraoperative blood loss in ml

  intaoperative periods

Secondary Outcomes (4)

• Patients needing blood transfusion

  intaoperative periods

• Red blood cell units transfused

  intaoperative periods

• portal pressure changes

  intaoperative periods

• ICU stay

  postoperative periods

Study Arms (2)

Terlipresssin

ACTIVE COMPARATOR

Terlipressin was started at the beginning of surgery, just after exposure of the portal vein and getting a basal portal pressure reading, as an initial bolus dose of 1 mg over 30 minutes (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 received the same volume of normal saline 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 is a synthetic vasopressin analogue with relative specificity for the splanchnic circulation(Terlipressin was 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

Terlipresssin

normal saline DRUG

Patients received 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 - 65 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,
• ASA classification class I and II,
• Patients assigned for Whipple procedure.

You may not qualify if:

• Preoperative renal failure,
• Severe liver dysfunction (Child-Turcotte-Pugh grade C),
• Hyponatremia (Na+ \<132mmol/l),
• Severe valvular heart disease,
• 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 \>160/100mmHg despite intensive treatment),
• Pregnancy.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Hemorrhage

Interventions

Terlipressin; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

• Assiut University hospital Egypt, Egypt

  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: Assiut-Egypt

Study Record Dates

• First Submitted: June 17, 2018
• First Posted: June 28, 2018
• Study Start: May 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 22, 2023

Record last verified: 2023-05