search
Back to results

High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation A Randomized, Controled, Open and Unicentric Trial. (LIVER-PAM)

Primary Purpose

Liver Transplant; Complications

Status
Recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Usual Care + High Target of Mean Arterial Pressure
Usual Care
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Transplant; Complications

Eligibility Criteria

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

Inclusion Criteria:

  • Older than 18 y
  • Admitted in the ICU for a post operative care after liver transplant

Exclusion Criteria:

  • Consent refusal
  • Liver transplant due to acute liver failure
  • Renal transplant ( Previous or concomitant)
  • Refusal from the healthcare provider responsible for the patient
  • Renal substitution therapy in the prior 15 days
  • Pregnancy
  • Re-Transplant (Liver transplant in the previous 6 month)
  • Hepatorenal syndrome current treatment (Use of terlipressin + Albumin)
  • Refractory and persistent shock during or after transplant

Sites / Locations

  • Hospital Das Clínicas Da Faculdade de Medicina Da Universidade de São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hihg Target Mean Arterial Pressure

Low Target Mean Arterial Pressure

Arm Description

Target of mean arterial pressure of 85-90 mmHg in ther first 24h after liver transplant.

Target of mean arterial pressure of 65-70 mmHg in ther first 24h after liver transplant.

Outcomes

Primary Outcome Measures

incidence of Acute Kidney Disfunction
Incidence of acute kidney Disfunction according to kdigo criteria.

Secondary Outcome Measures

Mortality
percentage of mortality in 28 days
re-transplant
percentage of re-transplant in 28 days
Lenght of Hospitay Stay
LOS in 28 days
Lenght of ICU Stay
ICU LOS in 28 days
Days alive and out of hospital in 28 days
Number of days alive and out of hospital in 28 days
Substitutive Renal Therapy
percentage of TSR in 7 days
Days Alive and free of renal disfunction
Days Alive and free of renal disfunction in 28 days
Acute kidney insufficiency according to Urinary NGAL on d0 and D2
Percentage of renal disfunction according to NGAL criteria on D0 and D2
MAKE28
Major Kidney Events ( Death, persistent acute kidney disfunction or need of RRT in 28 days)
Liver graft primary disfunction ( Initial Poor Function)
percentage of Initial Poor Function in 7 days
Liver graft primary disfunction (primary nonfunction)
percentage of primary nonfunction in 10 days
Surgical site infection
percentage of SSI in 28 days
Need of Transfusion
percentage of Transfusion requirement in 7 days
Postoperative Major bleeding in 7 days
Bleeding that requires 2 units of blood transfusion in a single day or the need of a reoperation due to bleeding in the first 24 hours after surgery.
Incidence of Arrythmia requiring clinical treatment
percentage of Arrhythmia requiring treatment in 7 days

Full Information

First Posted
September 24, 2021
Last Updated
May 17, 2023
Sponsor
University of Sao Paulo General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05068713
Brief Title
High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation A Randomized, Controled, Open and Unicentric Trial.
Acronym
LIVER-PAM
Official Title
High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
LIVER PAM A randomized, controled, open and unicentric trial comparing high (MAP 85-90 mmHg) and low (65-70 mmHg) target of mean arterial pressure in the first 24 hours after liver transplantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplant; Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hihg Target Mean Arterial Pressure
Arm Type
Experimental
Arm Description
Target of mean arterial pressure of 85-90 mmHg in ther first 24h after liver transplant.
Arm Title
Low Target Mean Arterial Pressure
Arm Type
Active Comparator
Arm Description
Target of mean arterial pressure of 65-70 mmHg in ther first 24h after liver transplant.
Intervention Type
Other
Intervention Name(s)
Usual Care + High Target of Mean Arterial Pressure
Intervention Description
Targeting the weaning of vasopressors to a mean arterial pressure of 85-90mmHg in the first 24h after liver trasnplant.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Targeting the weaning of vasopressors to a mean arterial pressure of 65-70mmHg in the first 24h after liver trasnplant.
Primary Outcome Measure Information:
Title
incidence of Acute Kidney Disfunction
Description
Incidence of acute kidney Disfunction according to kdigo criteria.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Mortality
Description
percentage of mortality in 28 days
Time Frame
28 days
Title
re-transplant
Description
percentage of re-transplant in 28 days
Time Frame
28 days
Title
Lenght of Hospitay Stay
Description
LOS in 28 days
Time Frame
28 days
Title
Lenght of ICU Stay
Description
ICU LOS in 28 days
Time Frame
28 days
Title
Days alive and out of hospital in 28 days
Description
Number of days alive and out of hospital in 28 days
Time Frame
28 days
Title
Substitutive Renal Therapy
Description
percentage of TSR in 7 days
Time Frame
7 days
Title
Days Alive and free of renal disfunction
Description
Days Alive and free of renal disfunction in 28 days
Time Frame
28 days
Title
Acute kidney insufficiency according to Urinary NGAL on d0 and D2
Description
Percentage of renal disfunction according to NGAL criteria on D0 and D2
Time Frame
0d and 2d
Title
MAKE28
Description
Major Kidney Events ( Death, persistent acute kidney disfunction or need of RRT in 28 days)
Time Frame
28 days
Title
Liver graft primary disfunction ( Initial Poor Function)
Description
percentage of Initial Poor Function in 7 days
Time Frame
7 days
Title
Liver graft primary disfunction (primary nonfunction)
Description
percentage of primary nonfunction in 10 days
Time Frame
10 days
Title
Surgical site infection
Description
percentage of SSI in 28 days
Time Frame
28 days
Title
Need of Transfusion
Description
percentage of Transfusion requirement in 7 days
Time Frame
7 days
Title
Postoperative Major bleeding in 7 days
Description
Bleeding that requires 2 units of blood transfusion in a single day or the need of a reoperation due to bleeding in the first 24 hours after surgery.
Time Frame
7 days
Title
Incidence of Arrythmia requiring clinical treatment
Description
percentage of Arrhythmia requiring treatment in 7 days
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Older than 18 y Admitted in the ICU for a post operative care after liver transplant Exclusion Criteria: Consent refusal Liver transplant due to acute liver failure Renal transplant ( Previous or concomitant) Refusal from the healthcare provider responsible for the patient Renal substitution therapy in the prior 15 days Pregnancy Re-Transplant (Liver transplant in the previous 6 month) Hepatorenal syndrome current treatment (Use of terlipressin + Albumin) Refractory and persistent shock during or after transplant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodolpho pedro, MD
Phone
+5511966470708
Email
rodolphopedro@hotmail.com
Facility Information:
Facility Name
Hospital Das Clínicas Da Faculdade de Medicina Da Universidade de São Paulo
City
São Paulo
State/Province
SAO Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RODOLPHO PEDRO, MD
Phone
+5511966470708
Email
rodolphopedro@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation A Randomized, Controled, Open and Unicentric Trial.

We'll reach out to this number within 24 hrs