Hospital Das Clínicas Da Faculdade de Medicina Da Universidade de São Paulo
São Paulo, 05403-000, Brazil
Completed
NCT Number: NCT05068713
High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation A Randomized, Controled, Open and Unicentric Trial.
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.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Usual Care + High Target of Mean Arterial Pressure
OtherTargeting the weaning of vasopressors to a mean arterial pressure of 85-90mmHg in the first 24h after liver trasnplant.
Usual Care
OtherTargeting the weaning of vasopressors to a mean arterial pressure of 65-70mmHg in the first 24h after liver trasnplant.
Primary outcomes
-
incidence of Acute Kidney Disfunction
Time frame: 7 days
Incidence of acute kidney Disfunction according to kdigo criteria.
Secondary outcomes
-
Mortality
Time frame: 28 days
percentage of mortality in 28 days
-
re-transplant
Time frame: 28 days
percentage of re-transplant in 28 days
-
Lenght of Hospitay Stay
Time frame: 28 days
LOS in 28 days
-
Lenght of ICU Stay
Time frame: 28 days
ICU LOS in 28 days
-
Days alive and out of hospital in 28 days
Time frame: 28 days
Number of days alive and out of hospital in 28 days
-
Substitutive Renal Therapy
Time frame: 7 days
percentage of TSR in 7 days
-
Days Alive and free of renal disfunction
Time frame: 28 days
Days Alive and free of renal disfunction in 28 days
-
Acute kidney insufficiency according to Urinary NGAL on d0 and D2
Time frame: 0d and 2d
Percentage of renal disfunction according to NGAL criteria on D0 and D2
-
MAKE28
Time frame: 28 days
Major Kidney Events ( Death, persistent acute kidney disfunction or need of RRT in 28 days)
-
Liver graft primary disfunction ( Initial Poor Function)
Time frame: 7 days
percentage of Initial Poor Function in 7 days
-
Liver graft primary disfunction (primary nonfunction)
Time frame: 10 days
percentage of primary nonfunction in 10 days
-
Surgical site infection
Time frame: 28 days
percentage of SSI in 28 days
-
Need of Transfusion
Time frame: 7 days
percentage of Transfusion requirement in 7 days
-
Postoperative Major bleeding in 7 days
Time frame: 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
Time frame: 7 days
percentage of Arrhythmia requiring treatment in 7 days
Sponsors and collaborators
Lead sponsor
University of Sao Paulo General Hospital
Other
Registry information
Official study title
High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation
Acronym: LIVER-PAM
Important dates
- Study start
- 2021
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Oct 6, 2021
- Registry last updated
- Jan 17, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Completed
Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children
NCT05818644
Hematologic Diseases, Hemic and Lymphatic Diseases
Groningen, Netherlands
View Trial Details
Completed
Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation
NCT05042505
Diabetes Mellitus, Endocrine System Diseases
Gurgaon, Haryana, India
View Trial Details
Completed
Effect of Cognitive Therapy on Immunosuppressive Treatment Compliance and Motivation
NCT06879106
Behavior, Compliance, Treatment
Bitlis, Turkey (Türkiye)
View Trial Details
Completed
Single-Cell and Spatial Transcriptomics Analysis of Steatotic Donor Liver Susceptibility to Post-Transplant Injury
NCT07362745
Digestive System Diseases, End Stage Liver Disease
Xi'an, Shaanxi, China
View Trial Details