Acute Kidney Injury, Acute Tubule Necrosis, Cirrhosis, Hepatorenal Syndrome, Portal Hypertension, Prerenal Failure
Conditions
Keywords
PRAGMATIC, FEASIBILITY
Brief summary
The goal of this pilot, randomized, single-blind clinical trial is to estimate the effect size of a high and low mean arterial pressure (MAP)-target algorithm among cirrhosis patients hospitalized with acute kidney injury. The main aims to answer are: • Does an algorithm that has low (\<80 mmHg) and high (≥80) MAP-targets lead to significant differences in mean arterial pressure? • Are there any serious adverse events (e.g., ischemia) in a high blood pressure algorithm as compared to a low blood pressure algorithm? • Are there any differences in the incidence of AKI reversal in the high v. low MAP-target groups? Participants will be: 1) Randomized to a clinical algorithm that will either target a low (\<80 mmHg) or high (≥80 mmHg) MAP. 2) Depending on their group, investigators will titrate commonly used medications to a specific MAP target. Researchers will compare the high and low MAP-target groups to see if these algorithms lead to significant changes in MAP, if they have any impact on AKI reversal, and if there are any adverse events in the high MAP-target group.
Interventions
DRUGMAP-Target Algorithm
This is a clinical treatment algorithm that will determine the escalation and deescalation of vasoconstrictor utilization based on a target MAP, either high (≥80 mmHg) in the treatment group and low (\< 80 mmHg) in the comparator group.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This is single blind. The participants will be blinded to their intervention arm. The treating providers will not be blinded as they will receive either the low or high MAP-target treatment algorithm.
Intervention model description
This is a single-blind, randomized control, parallel-group, pragmatic trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized patients with decompensated cirrhosis, defined as a Child-Pugh Score ≥ 7 * Acute Kidney Injury: a ≥50% increase in sCr from an outpatient baseline sCr measured 7 to 365 days prior to admission
Exclusion criteria
1. Patients without a baseline (7 - 365 days prior to AKI development) sCr measurement; 2. Patients who are already on kidney replacement therapy (KRT) at the time of enrollment; 3. Patients with an oxygen requirement greater than 6L via nasal cannula; 4. Patients with a serum creatinine level exceeding 5 mg/dL.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in mean arterial pressure. | 14 days. | The investigators will determine if a high, as compared to a low, MAP-target algorithm leads to significantly different changes in MAP. This will be completed by comparing the change in MAP from the baseline to the completion of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury reversal. | 14 days | The investigators will determine if a high, as compared to a low, MAP-target algorithm leads to significantly different incidences of acute kidney injury reversal. This will be defined as a decrease in serum creatinine (sCr) to within 0.3 mg/dL of the baseline sCr. |
Countries
United States
Outcome results
None listed