Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU

ConditionCritical Illness

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorHospital do Coracao

About this trial

Renal dysfunction is a frequent complication in patients admitted to intensive care units (ICUs), associated with high morbidity and mortality. Current therapeutic options to prevent this condition are limited and lack robust scientific evidence. This pilot study consists of a multicenter, blinded, randomized clinical trial, unprecedented in the literature to date, aiming to fill this knowledge gap and offer new therapeutic perspectives to improve renal outcomes in critically ill patients admitted to the ICU.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years old);

Admitted to intensive care units;

Predicted risk of acute kidney injury calculated based on clinical and laboratory data at ICU admission and is considered eligible if the value in the calculator is equal or greater than 5 points;

Disqualifiers

Time since admission to the ICU greater than 24 hours;

Use of vasopressors at the time of inclusion;

MAP >90 mmHg;

Hyponatremia (<130 mmol/L);

Trial design

Design model

Parallel

Treatments tested in this trial

Vasopressin
Drug
To dilute vasopressin, an ampoule containing 20 IU/ml (1 ml) of vasopressin will be used, which will be mixed with 100 ml of 0.9% physiological solution, resulting in a solution with a concentration of 0.2 IU/ ml. In this study, both central and peripheral vein infusion will be permitted. The vasopressin administration protocol will consist of an initial dose of 0.02 IU/min (equivalent to 6 ml/h), which can be increased to 0.03 IU/min (9 ml/h) if the mean arterial pressure (MAP) is less than or equal to 65 mmHg. On the other hand, if MAP exceeds 90 mmHg, the dose can be reduced to 0.01 IU/min (3 ml/h). The minimum period for adjusting the drug dosage should be one hour.
0,9% saline solution
Other intervention
Similar to the intervention protocol, but using a placebo composed of 0.9% saline solution.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: VasopressinExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Feasibility

Defined by the inclusion of 60 patients in 3 or more ICUs over a period of 6 months

Time frame

6 months

Secondary outcomes

Creatinine, in mg/dL

Creatinine will be defined by laboratory analysis

Time frame

7 days

Other outcomes

Mortality

Mortality will be defined by medical records

Time frame

30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital do Coracao

Lead sponsor

Source ClinicalTrials.gov

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