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Clinical Trials/NCT05068713
NCT05068713CompletedPhase 3

High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation

University of Sao Paulo General Hospital2 sites in 1 country174 target enrollmentStarted: August 24, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
174
Locations
2
Primary Endpoint
incidence of Acute Kidney Disfunction
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

incidence of Acute Kidney Disfunction

Time Frame: 7 days

Incidence of acute kidney Disfunction according to kdigo criteria.

Secondary Outcomes

  • Days alive and out of hospital in 28 days(28 days)
  • re-transplant(28 days)
  • Lenght of Hospitay Stay(28 days)
  • Substitutive Renal Therapy(7 days)
  • MAKE28(28 days)
  • Mortality(28 days)
  • Need of Transfusion(7 days)
  • Postoperative Major bleeding in 7 days(7 days)
  • Days Alive and free of renal disfunction(28 days)
  • Acute kidney insufficiency according to Urinary NGAL on d0 and D2(0d and 2d)
  • Liver graft primary disfunction (primary nonfunction)(10 days)
  • Liver graft primary disfunction ( Initial Poor Function)(7 days)
  • Lenght of ICU Stay(28 days)
  • Incidence of Arrythmia requiring clinical treatment(7 days)
  • Surgical site infection(28 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rodolpho Augusto de Moura Pedro

Principal investigator

University of Sao Paulo General Hospital

Study Sites (2)

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