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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low MAP-Target | Active Comparator | This group will be randomized to a treatment algorithm that utilizes a low MAP-target (<80 mmHg) to determine if titration of vasoconstrictors is needed. |
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| High MAP-Target | Active Comparator | This group will be randomized to a treatment algorithm that utilizes a high MAP-target (≥80 mmHg) to determine if titration of vasoconstrictors is needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAP-Target Algorithm | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in mean arterial pressure. | 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. | 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute kidney injury reversal. | 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. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
Participant eligibility is based on self-representation of gender identity.
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Cullaro, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
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This is a single-blind, randomized control, parallel-group, pragmatic trial.
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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.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 4, 2025 | Aug 20, 2025 | 4 | ||
| Oct 24, 2025 | Nov 7, 2025 | 5 |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D005355 | Fibrosis |
| D006975 | Hypertension, Portal |
| D006530 | Hepatorenal Syndrome |
| D007673 | Kidney Cortex Necrosis |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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