High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation A Randomized, Controled, Open and Unicentric Trial.
LIVER-PAM
1 other identifier
interventional
174
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2021
CompletedFirst Submitted
Initial submission to the registry
September 24, 2021
CompletedFirst Posted
Study publicly available on registry
October 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2024
CompletedJanuary 17, 2024
January 1, 2024
2.4 years
September 24, 2021
January 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
incidence of Acute Kidney Disfunction
Incidence of acute kidney Disfunction according to kdigo criteria.
7 days
Secondary Outcomes (15)
Mortality
28 days
re-transplant
28 days
Lenght of Hospitay Stay
28 days
Lenght of ICU Stay
28 days
Days alive and out of hospital in 28 days
28 days
- +10 more secondary outcomes
Study Arms (2)
Hihg Target Mean Arterial Pressure
EXPERIMENTALTarget of mean arterial pressure of 85-90 mmHg in ther first 24h after liver transplant.
Low Target Mean Arterial Pressure
ACTIVE COMPARATORTarget of mean arterial pressure of 65-70 mmHg in ther first 24h after liver transplant.
Interventions
Targeting the weaning of vasopressors to a mean arterial pressure of 85-90mmHg in the first 24h after liver trasnplant.
Targeting the weaning of vasopressors to a mean arterial pressure of 65-70mmHg in the first 24h after liver trasnplant.
Eligibility Criteria
You may qualify if:
- Older than 18 y
- Admitted in the ICU for a post operative care after liver transplant
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Das Clínicas Da Faculdade de Medicina Da Universidade de São Paulo
São Paulo, São Paulo, 05403-000, Brazil
Related Publications (1)
Pedro RAM, Scharranch BC, Araujo LO, Brandao LS, Andrade LDC, Andraus W, D'Albuquerque LAC, Malbouisson LMS. High versus low mean arterial pressure target in liver transplant patients. An open, controlled, single-center, randomized clinical trial - Protocol and methods (LIVER-PAM). Crit Care Sci. 2023 Mar 1;35(1):11-18. doi: 10.5935/2965-2774.20230336-en.
PMID: 37712725DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
September 24, 2021
First Posted
October 6, 2021
Study Start
August 24, 2021
Primary Completion
January 5, 2024
Study Completion
January 5, 2024
Last Updated
January 17, 2024
Record last verified: 2024-01