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Angiotensin II in Liver Transplantation (AngLT-1)

Primary Purpose

Liver Transplant; Complications, Vasoplegia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Angiotensin II
Saline
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Transplant; Complications focused on measuring Vasoplegia, Angiotensin II, Cirrhosis, Liver Transplant, Liver Transplantation, Hypotension, Acute Kidney Injury

Eligibility Criteria

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

Inclusion Criteria:

  • Age > or = 18 years
  • Liver transplantation from a deceased donor
  • Model for End-stage Liver Disease Sodium (MELD-Na) score > or = 25 at the time of transplant (not counting MELD exception points)
  • Patient requiring > 0.05 mcg/kg/min of norepinephrine (NE) during LT

Exclusion Criteria:

  • Living-donor liver transplantation (LDLT)
  • Split liver transplantation (isolated right or left lobe)
  • Donation after cardiac death (DCD) without normothermic machine perfusion (NMP)
  • Acute liver failure (ALF)
  • Listed for or receiving simultaneous liver-kidney transplantation (SLKT)
  • Liver re-transplantation (patient who has previously received a liver transplant)
  • Preoperative treatment with angiotensin II receptor blocker or angiotensin converting enzyme inhibitor (within 48 h)
  • Portopulmonary hypertension
  • Left ventricular systolic dysfunction (defined as ejection fraction < 45%)
  • Active bronchospasm at time of LT
  • History of thrombotic or embolic disease, inherited hypercoagulable disorder, or therapeutic anticoagulation
  • Portal vein thrombosis
  • Celiac stenosis
  • End-stage renal disease (chronic eGFR < 15 mL/min/1.73 m2 or chronic RRT - not including AKI requiring RRT)
  • History of Raynaud's disease
  • Known history of allergy to synthetic human angiotensin II
  • Subject intubated and/or mechanically ventilated prior to entering OR for LT
  • Presence of other condition or abnormality that would compromise the safety of the patient or quality of the data

Sites / Locations

  • University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Angiotensin II (Giapreza)

Saline

Arm Description

Giapreza (synthetic human angiotensin II), initiated at 5 ng/kg/min and titrated to between 1.25 ng/kg/min and 40 ng/kg/min, administered by continuous intravenous infusion.

Sterile 0.9% saline, initiated and titrated at an equivalent volume infusion rate to the study drug, administered by continuous intravenous infusion.

Outcomes

Primary Outcome Measures

Total dose of norepinephrine (NE), averaged over case duration and total body weight, utilized during liver transplantation (LT) to maintain mean arterial pressure (MAP) greater than or equal to 65 mmHg.
Calculated as the sum of all NE doses (in mcg) administered by either infusion or bolus during LT surgery, divided by the subjects total body weight (TBW, in kg), divided by the duration of surgery (in min). The Primary Outcome will be expressed in mcg/kg/min.

Secondary Outcome Measures

Proportion of patients requiring 3rd and 4th line vasopressor infusions (epinephrine or vasopressin) during LT
The proportion of patients requiring 3rd and 4th line vasopressors (epinephrine or vasopressin, at the anesthesiologists discretion) in addition to NE and Study Drug to be administered by infusion for greater than or equal to 5 min during each of the following phases of LT will be tabulated: Dissection phase - begins at the time of skin incision and ends with clamping of the inferior vena cava (IVC) Anhepatic phase - begins at the time of IVC clamping and ends with unclamping of the portal vein Neohepatic phase - begins at the time of portal vein unclamping and ends at the time of skin closure
Time spent below target MAP (65 mmHg)
Total time in minutes that the patient has a MAP <65 mmHg during LT.
Dose of vasopressin administered during LT, averaged over case duration and TBW.
Calculated as the sum of all vasopressin doses (in units) administered by either infusion or bolus during LT surgery, divided by the subject's TBW (in kg), divided by the duration of surgery (in hr). Expressed in units/kg/hr.
Dose of epinephrine administered during LT, excluding boluses within the 5 min immediately following portal reperfusion, averaged over case duration and TBW.
Calculated as the sum of all epinephrine doses (in mcg) administered by either infusion or bolus during LT surgery, divided by the subject's TBW (in kg), divided by the duration of surgery (in min). Expressed in mcg/kg/min. Boluses of epinephrine given from 0 to 5 min after portal vein reperfusion will be excluded.
Change in direct renin
Change in plasma direct renin level from the time of surgical incision to 2 hours after reperfusion of the portal vein
Incidence of severe (stage 2 or 3) acute kidney injury (AKI) within 48 hours after LT.
The incidence of severe AKI (stage 2 or 3) is defined according to the International Club for Ascites (ICA) 2015 criteria, a revision of the Kidney Disease Improving Global Outcomes (KDIGO) criteria for patients with cirrhosis. Severe AKI is defined as an increase in sCr > 2-fold from baseline, or sCr ≥ 4.0 with an acute increase of ≥ 0.3 mg/dL from baseline, or initiation of RRT. The baseline sCr is defined as the most recent value prior to LT. Limited to the stratum of patients not on RRT immediately prior to surgery.
Change in intraoperative urine output in mL/kg/hr before and after initiation of study drug
Intraoperative urine output will be continuously monitored using an automated meter (Accuryn Monitoring System, Potrero Medical). The change in the rate of urine output will be compared before and after initiation of the study drug.
Major adverse kidney events (MAKE) at 30 days (MAKE-30) after LT
Defined as the composite of death, RRT, or a 25% reduction in estimated glomerular filtration rate (eGFR) by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at 30 days after LT.
Incidence of early allograft dysfunction (EAD) by Olthoff criteria
Defined by one or more of the following: Total bilirubin ≥ 10 mg/dL on postoperative day (POD) 7 International normalized ratio (INR) ≥ 1.6 on POD 7 Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2000 units/L within the first 7 days after LT
Model for Early Allograft Function (MEAF) score
Calculated from the maximum ALT and INR within the first 3 PODs and the total bilirubin on POD 3. The MEAF score ranges from 0-10 with higher scores indicating worse liver function (i.e., more severe early allograft dysfunction) in the early postoperative period.
Duration of renal replacement therapy (RRT) after LT
Total duration of RRT following LT, limited to the stratum of subjects on RRT immediately prior to surgery.
Duration of ICU stay after LT
Total duration of intensive care unit stay following LT.
Duration of hospital stay after LT
Total duration of hospital stay after LT
Patient and graft survival at 30 days after LT
Defined as patient death or need for re-transplant within 30 days following LT.
Patient and graft survival at 1 year after LT
Defined as patient death or need for re-transplant within 1 year following LT.

Full Information

First Posted
May 20, 2021
Last Updated
December 14, 2022
Sponsor
University of California, San Francisco
Collaborators
La Jolla Pharmaceutical Company
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1. Study Identification

Unique Protocol Identification Number
NCT04901169
Brief Title
Angiotensin II in Liver Transplantation
Acronym
AngLT-1
Official Title
Angiotensin II in Liver Transplantation (AngLT-1): A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
La Jolla Pharmaceutical Company

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to determine the efficacy and safety of Angiotensin II as a second-line vasopressor (drug that raises the blood pressure) during liver transplantation.
Detailed Description
This is a single center, randomized, double-blind, placebo-controlled trial. Subjects will receive an infusion of either Angiotensin II (AngII) or a saline control (placebo) in addition to usual care with traditional vasopressors (catecholamines and vasopressin) during liver transplantation (LT). AngII is a vasopressor approved by the FDA for the treatment of vasodilatory shock. It targets the renin-angiotensin system (RAS) and has been shown to effectively raise the mean arterial blood pressure (MAP) in patients with septic shock. It also allows for lower doses of traditional vasopressors and may improve microcirculatory flow to the kidneys. The study drug will only be administered if the participants require > 0.05 mcg/kg/min of norepinephrine while undergoing liver transplantation. The study drug will be titrated throughout the case and discontinued at the end of surgery. Randomization will be stratified based on (a) the need for renal replacement therapy preoperatively and (b) the use of normothermic machine perfusion of the liver graft.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplant; Complications, Vasoplegia
Keywords
Vasoplegia, Angiotensin II, Cirrhosis, Liver Transplant, Liver Transplantation, Hypotension, Acute Kidney Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Identically-labeled infusion bags of either angiotensin II or saline placebo will be prepared by a research pharmacist.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Angiotensin II (Giapreza)
Arm Type
Experimental
Arm Description
Giapreza (synthetic human angiotensin II), initiated at 5 ng/kg/min and titrated to between 1.25 ng/kg/min and 40 ng/kg/min, administered by continuous intravenous infusion.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Sterile 0.9% saline, initiated and titrated at an equivalent volume infusion rate to the study drug, administered by continuous intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Angiotensin II
Other Intervention Name(s)
Giapreza (synthetic human angiotensin II)
Intervention Description
Infusion of Angiotensin II initiated if participants require norepinephrine at a rate of > 0.05 mcg/kg/min. The infusion will be titrated no more frequently than every 10 minutes during liver transplantation as a second line vasopressor and discontinued prior to leaving the operating room when the surgery is complete.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
0.9% normal saline
Intervention Description
Infusion of 0.9% saline initiated if participants require norepinephrine at a rate of > 0.05 mcg/kg/min. The infusion will be titrated no more frequently than every 10 minutes during liver transplantation as a second line vasopressor and discontinued prior to leaving the operating room when the surgery is complete.
Primary Outcome Measure Information:
Title
Total dose of norepinephrine (NE), averaged over case duration and total body weight, utilized during liver transplantation (LT) to maintain mean arterial pressure (MAP) greater than or equal to 65 mmHg.
Description
Calculated as the sum of all NE doses (in mcg) administered by either infusion or bolus during LT surgery, divided by the subjects total body weight (TBW, in kg), divided by the duration of surgery (in min). The Primary Outcome will be expressed in mcg/kg/min.
Time Frame
Duration of surgery - defined as the time period starting with skin incision by the surgeon, and ending at the time of skin closure, an average of 8 hours.
Secondary Outcome Measure Information:
Title
Proportion of patients requiring 3rd and 4th line vasopressor infusions (epinephrine or vasopressin) during LT
Description
The proportion of patients requiring 3rd and 4th line vasopressors (epinephrine or vasopressin, at the anesthesiologists discretion) in addition to NE and Study Drug to be administered by infusion for greater than or equal to 5 min during each of the following phases of LT will be tabulated: Dissection phase - begins at the time of skin incision and ends with clamping of the inferior vena cava (IVC) Anhepatic phase - begins at the time of IVC clamping and ends with unclamping of the portal vein Neohepatic phase - begins at the time of portal vein unclamping and ends at the time of skin closure
Time Frame
Duration of surgery - defined as the time period starting with skin incision by the surgeon, and ending at the time of skin closure, an average of 8 hours.
Title
Time spent below target MAP (65 mmHg)
Description
Total time in minutes that the patient has a MAP <65 mmHg during LT.
Time Frame
Duration of surgery - defined as the time period starting with skin incision by the surgeon, and ending at the time of skin closure, an average of 8 hours.
Title
Dose of vasopressin administered during LT, averaged over case duration and TBW.
Description
Calculated as the sum of all vasopressin doses (in units) administered by either infusion or bolus during LT surgery, divided by the subject's TBW (in kg), divided by the duration of surgery (in hr). Expressed in units/kg/hr.
Time Frame
Duration of surgery - defined as the time period starting with skin incision by the surgeon, and ending at the time of skin closure, an average of 8 hours.
Title
Dose of epinephrine administered during LT, excluding boluses within the 5 min immediately following portal reperfusion, averaged over case duration and TBW.
Description
Calculated as the sum of all epinephrine doses (in mcg) administered by either infusion or bolus during LT surgery, divided by the subject's TBW (in kg), divided by the duration of surgery (in min). Expressed in mcg/kg/min. Boluses of epinephrine given from 0 to 5 min after portal vein reperfusion will be excluded.
Time Frame
Duration of surgery - defined as the time period starting with skin incision by the surgeon, and ending at the time of skin closure, an average of 8 hours.
Title
Change in direct renin
Description
Change in plasma direct renin level from the time of surgical incision to 2 hours after reperfusion of the portal vein
Time Frame
Time of surgical incision and 2 hours after reperfusion of the portal vein, approximately 4 hours.
Title
Incidence of severe (stage 2 or 3) acute kidney injury (AKI) within 48 hours after LT.
Description
The incidence of severe AKI (stage 2 or 3) is defined according to the International Club for Ascites (ICA) 2015 criteria, a revision of the Kidney Disease Improving Global Outcomes (KDIGO) criteria for patients with cirrhosis. Severe AKI is defined as an increase in sCr > 2-fold from baseline, or sCr ≥ 4.0 with an acute increase of ≥ 0.3 mg/dL from baseline, or initiation of RRT. The baseline sCr is defined as the most recent value prior to LT. Limited to the stratum of patients not on RRT immediately prior to surgery.
Time Frame
48 hours
Title
Change in intraoperative urine output in mL/kg/hr before and after initiation of study drug
Description
Intraoperative urine output will be continuously monitored using an automated meter (Accuryn Monitoring System, Potrero Medical). The change in the rate of urine output will be compared before and after initiation of the study drug.
Time Frame
Duration of surgery - defined as the time period starting with skin incision by the surgeon, and ending at the time of skin closure, an average of 8 hours.
Title
Major adverse kidney events (MAKE) at 30 days (MAKE-30) after LT
Description
Defined as the composite of death, RRT, or a 25% reduction in estimated glomerular filtration rate (eGFR) by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at 30 days after LT.
Time Frame
30 days
Title
Incidence of early allograft dysfunction (EAD) by Olthoff criteria
Description
Defined by one or more of the following: Total bilirubin ≥ 10 mg/dL on postoperative day (POD) 7 International normalized ratio (INR) ≥ 1.6 on POD 7 Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2000 units/L within the first 7 days after LT
Time Frame
7 days
Title
Model for Early Allograft Function (MEAF) score
Description
Calculated from the maximum ALT and INR within the first 3 PODs and the total bilirubin on POD 3. The MEAF score ranges from 0-10 with higher scores indicating worse liver function (i.e., more severe early allograft dysfunction) in the early postoperative period.
Time Frame
3 days
Title
Duration of renal replacement therapy (RRT) after LT
Description
Total duration of RRT following LT, limited to the stratum of subjects on RRT immediately prior to surgery.
Time Frame
Up to 1 year
Title
Duration of ICU stay after LT
Description
Total duration of intensive care unit stay following LT.
Time Frame
Up to 1 year
Title
Duration of hospital stay after LT
Description
Total duration of hospital stay after LT
Time Frame
Up to 1 year
Title
Patient and graft survival at 30 days after LT
Description
Defined as patient death or need for re-transplant within 30 days following LT.
Time Frame
30 days
Title
Patient and graft survival at 1 year after LT
Description
Defined as patient death or need for re-transplant within 1 year following LT.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > or = 18 years Liver transplantation from a deceased donor Model for End-stage Liver Disease Sodium (MELD-Na) score > or = 25 at the time of transplant (not counting MELD exception points) Patient requiring > 0.05 mcg/kg/min of norepinephrine (NE) during LT Exclusion Criteria: Living-donor liver transplantation (LDLT) Split liver transplantation (isolated right or left lobe) Donation after cardiac death (DCD) without normothermic machine perfusion (NMP) Acute liver failure (ALF) Listed for or receiving simultaneous liver-kidney transplantation (SLKT) Liver re-transplantation (patient who has previously received a liver transplant) Preoperative treatment with angiotensin II receptor blocker or angiotensin converting enzyme inhibitor (within 48 h) Portopulmonary hypertension Left ventricular systolic dysfunction (defined as ejection fraction < 45%) Active bronchospasm at time of LT History of thrombotic or embolic disease, inherited hypercoagulable disorder, or therapeutic anticoagulation Portal vein thrombosis Celiac stenosis End-stage renal disease (chronic eGFR < 15 mL/min/1.73 m2 or chronic RRT - not including AKI requiring RRT) History of Raynaud's disease Known history of allergy to synthetic human angiotensin II Subject intubated and/or mechanically ventilated prior to entering OR for LT Presence of other condition or abnormality that would compromise the safety of the patient or quality of the data
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael P Bokoch, M.D., Ph.D.
Phone
(415) 476-8389
Email
michael.bokoch@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Bokoch, M.D., Ph.D.
Organizational Affiliation
Department of Anesthesia and Perioperative Care, University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael P Bokoch, MD, PhD
Phone
415-476-8389
Email
Michael.Bokoch@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Dieter Adelmann, MD, PhD
Email
Dieter.Adelmann@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Michael P Bokoch, MD, PhD
First Name & Middle Initial & Last Name & Degree
Matthieu M Legrand, MD, PhD
First Name & Middle Initial & Last Name & Degree
Garrett R Roll, MD
First Name & Middle Initial & Last Name & Degree
Dieter Adelmann, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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Angiotensin II in Liver Transplantation

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