Norepinephrine Boluses in Liver Transplantation

NCT03773276 | Completed Phase 1

• 1 other identifier: R.18.11.323 - 2018/11/05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 10 µg adrenaline boluses.

Conditions

Living Donor Liver Transplantation; Norepinephrine Bolus; Postperfusion Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of postreperfusion syndrome

  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

  5 minutes after reperfusion

Secondary Outcomes (6)

• Arrhythmia

  During and 5 minutes after norepinephrine boluses

• Ischemia

  During and 5 minutes after norepinephrine boluses

• Liver graft function

  After 2 days postoperative

• Acute kidney injury

  within the first 2 days postoperative

• 3-month survival

  90 days after surgery

Study Arms (1)

Norepinephrine boluses

EXPERIMENTAL

Single arm study

Drug: Norepinephrine boluses

Interventions

Norepinephrine boluses DRUG

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 10 µg adrenaline boluses.

Also known as: Noradrenaline boluses

Norepinephrine boluses

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 subjected to living donor liver transplantation with right lobe liver graft.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Gastrointestinal Surgery Center, Liver Transplantation

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Study Officials

• Amr M Yassen, Professor

  Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a feasibility (efficacy and safety) trial that tests the Norepinephrine boluses for the prevention of postreperfusion syndrome during liver transplantation operation.

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 12, 2018
• Study Start: December 17, 2018
• Primary Completion: April 18, 2020
• Study Completion: August 28, 2020
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)