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

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ClinicalTrials.gov Identifier: NCT02588716
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Mostafa Samy Abbas, Assiut University

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

Condition or disease Intervention/treatment Phase
Hepatectomy, Surgical Blood Loss, Terlipressin Drug: Terlipressin Drug: normal saline Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.
Study Start Date : September 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Terlipressin
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(1 mg over 30 mins) followed by a continuous infusion of 2μg/kg/h to be continued throughout the surgery then gradually withdrawn over 4 hours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
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.
Other Name: glipressin

Placebo Comparator: Control
same volumes of normal saline with the same rate of infusion, throughout the operation then gradually withdrawn over 4 hours.
Drug: normal saline
Same volumes of normal saline infusion, throughout the operation then gradually withdrawn over 4 hours.




Primary Outcome Measures :
  1. blood loss [ Time Frame: intraoperative period ]
    blood loss in ml


Secondary Outcome Measures :
  1. blood units transfused [ Time Frame: intraoperative period ]
    number of packed RBCs units transfused

  2. lactate level [ Time Frame: at start and end of resection ]
    lactate level in blood gas sample in mmol/L



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588716


Locations
Egypt
Assiut University hospital
Assiut, Asyut Governorate, Egypt, 11111
Sponsors and Collaborators
Assiut University

Responsible Party: Mostafa Samy Abbas, Lecturer, of Anesthesia & ICU, Assiut University, Assiut University
ClinicalTrials.gov Identifier: NCT02588716     History of Changes
Other Study ID Numbers: Terlipressin
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: July 2015

Keywords provided by Mostafa Samy Abbas, Assiut University:
Hepatectomy, Surgical Blood Loss, terlipressin

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Terlipressin
Lypressin
Antihypertensive Agents
Vasoconstrictor Agents
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs