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

NCT ID: NCT05068713

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-24

Study Completion Date

2024-01-05

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Transplant; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hihg Target Mean Arterial Pressure

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

Group Type EXPERIMENTAL

Usual Care + High Target of Mean Arterial Pressure

Intervention Type OTHER

Targeting the weaning of vasopressors to a mean arterial pressure of 85-90mmHg in the first 24h after liver trasnplant.

Low Target Mean Arterial Pressure

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Targeting the weaning of vasopressors to a mean arterial pressure of 65-70mmHg in the first 24h after liver trasnplant.

Interventions

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Usual Care + High Target of Mean Arterial Pressure

Targeting the weaning of vasopressors to a mean arterial pressure of 85-90mmHg in the first 24h after liver trasnplant.

Intervention Type OTHER

Usual Care

Targeting the weaning of vasopressors to a mean arterial pressure of 65-70mmHg in the first 24h after liver trasnplant.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rodolpho Augusto de Moura Pedro

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Das Clínicas Da Faculdade de Medicina Da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 37712725 (View on PubMed)

Other Identifiers

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LIVER-PAM

Identifier Type: -

Identifier Source: org_study_id

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