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

Primary Purpose

Terlipressin, Blood Loss

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Terlipressin
normal saline
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Terlipressin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients older than 18 years of age,
  • ASA classification class I and II,
  • Patients assigned for Whipple procedure.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Terlipresssin

    Control

    Arm Description

    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.

    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)

    Outcomes

    Primary Outcome Measures

    Intraoperative blood loss
    Amount of intraoperative blood loss in ml

    Secondary Outcome Measures

    Patients needing blood transfusion
    Number of patients needing blood transfusion
    Red blood cell units transfused
    The number of red blood cell units transfused
    portal pressure changes
    portal pressure changes in mmHg
    ICU stay
    ICU stay in days

    Full Information

    First Posted
    June 17, 2018
    Last Updated
    May 19, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03572088
    Brief Title
    Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs
    Official Title
    Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2016 (Actual)
    Primary Completion Date
    July 2017 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Terlipressin, Blood Loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Terlipresssin
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    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)
    Intervention Type
    Drug
    Intervention Name(s)
    Terlipressin
    Other Intervention Name(s)
    glypressin
    Intervention Description
    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.)
    Intervention Type
    Drug
    Intervention Name(s)
    normal saline
    Other Intervention Name(s)
    0.9 Nacl
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Intraoperative blood loss
    Description
    Amount of intraoperative blood loss in ml
    Time Frame
    intaoperative periods
    Secondary Outcome Measure Information:
    Title
    Patients needing blood transfusion
    Description
    Number of patients needing blood transfusion
    Time Frame
    intaoperative periods
    Title
    Red blood cell units transfused
    Description
    The number of red blood cell units transfused
    Time Frame
    intaoperative periods
    Title
    portal pressure changes
    Description
    portal pressure changes in mmHg
    Time Frame
    intaoperative periods
    Title
    ICU stay
    Description
    ICU stay in days
    Time Frame
    postoperative periods

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients older than 18 years of age, ASA classification class I and II, Patients assigned for Whipple procedure. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Assiut University hospital Egypt, Egypt
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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