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Norepinephrine Boluses for Prevention of Postreperfusion Syndrome in Living Donor Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773276
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Brief Summary:

We study the efficacy of Norepinephrine boluses on prevention of postreperfusion syndrome during living donor liver transplantation.

NE and Post-reperfusion:

On portal vein declamping, we will start rapid 500 ml 4% albumin infusion or packed RBCs (according to the anhepatic hemoglobin level 5 min before declamping) through 14 Gauge peripheral venous cannula in all patients.

NE boluses technique; We will inject NE boluses in the C.V.P port of the pulmonary artery catheter with 5 ml saline flushing after each. After reperfusion, we will start bolus noradrenaline 20 µg if mean arterial blood pressure (mABP) decreases by 10 % or more of the basal reading (immediately before portal vein declamping after ensuring withholding of the surgical manipulation). Additional NE boluses will be given as follow;

  • If mABP rises to 65 mmHg (lowest target level), we will hold NE boluses.
  • If mABP remains constant or begins to rise but did not reach 65 mmHg, we will give 20 µg after 10 seconds from the previous bolus
  • If mABP continues to drop, we will add 10 µg to the previous dose after 10 seconds and can be repeated.
  • If mABP remains below 65 mmHg more than 1 minute, we will give the scheduled bolus NE with adding 20 µg adrenaline boluses.

Condition or disease Intervention/treatment Phase
Living Donor Liver Transplantation Norepinephrine Bolus Postperfusion Syndrome Drug: Norepinephrine boluses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Norepinephrine Boluses for Prevention of Postreperfusion Syndrome in Living Donor Liver Transplantation
Actual Study Start Date : November 25, 2018
Actual Primary Completion Date : April 18, 2020
Actual Study Completion Date : August 28, 2020

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Arm Intervention/treatment
Experimental: Norepinephrine boluses
Single arm study
Drug: Norepinephrine boluses

On portal vein declamping, We will inject NE boluses in the C.V.P port of the pulmonary artery catheter with 5 ml saline flushing after each. After reperfusion, we will start bolus noradrenaline 20 µg if mean arterial blood pressure (mABP) decreases by 10 % or more of the basal reading (immediately before portal vein declamping after ensuring withholding of the surgical manipulation). Additional NE boluses will be given as follow;

  • If mABP rises to 65 mmHg (lowest target level), we will hold NE boluses.
  • If mABP remains constant or begins to rise but did not reach 65 mmHg, we will give 20 µg after 10 seconds from the previous bolus
  • If mABP continues to drop, we will add 10 µg to the previous dose after 10 seconds and can be repeated.
  • If mABP remains below 65 mmHg more than 1 minute, we will give the scheduled bolus NE with adding 20 µg adrenaline boluses.




Primary Outcome Measures :
  1. Incidence of postreperfusion syndrome [ Time Frame: 5 minutes after reperfusion ]
    PRS defined as 30% drop in the mABP when compared to the mABP just before portal declamping sustained for 1 min within the first 5 min after portal unclamping


Secondary Outcome Measures :
  1. Arrhythmia [ Time Frame: During and 5 minutes after norepinephrine boluses ]
    if significant and persistent

  2. Ischemia [ Time Frame: During and 5 minutes after norepinephrine boluses ]
    ST depression more than 1mV in lead II

  3. Liver graft function [ Time Frame: After 2 days postoperative ]
    By pH, serum lactate mmol/l, INR, AST u/ml, ALT u/ml, albumin gm/dl and bilirubin ml/dl as a composite outcome

  4. Acute kidney injury [ Time Frame: within the first 2 days postoperative ]
    50% increase in the S.Cr or 0.3 mg/dl increase from the baseline S.Cr in the early 48 post¬operative hours



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients subjected to living donor liver transplantation with right lobe liver graft.

Exclusion Criteria:

  1. Acute fulminant hepatitis
  2. Chronic hypertension
  3. Moderate to severe valvular heart disease
  4. Chronic kidney disease (CKD) and Hepatorenal syndrome (HRS)
  5. Preoperative S.Cr elevation > 1.4 mg/kg or dialysis recently before surgery
  6. Long standing diabetes mellitus (> 10 years on insulin)
  7. Moderate and sever Porto-pulmonary hypertension
  8. Moderate and sever Hepato-pulmonary syndrome (HPS)
  9. Contraindications to pulmonary artery catheter insertion
  10. Budd Chiari syndrome
  11. Re-transplantation
  12. Massive blood transfusion (more than 5 units of blood before portal clamping)
  13. Graft/weight ratio > 1.4 and < 0.8

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): NCT03773276


Locations
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Egypt
Mansoura University, Gastrointestinal Surgery Center, Liver Transplantation
Mansoura, Dakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Study Director: Amr M Yassen, Professor Mansoura University
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03773276    
Other Study ID Numbers: R.18.11.323 - 2018/11/05
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents