Continuous Renal Replacement Therapy Doses in Critically Ill Patients With Acute Kidney Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2027-08-31

Brief Summary

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Acute kidney injury in critically ill patients admitted to the ICU is a common complication associated with high mortality or long-term chronic kidney damage. Some of these patients require continuous renal replacement therapy (low-intensity hemodialysis for 24 hours) until renal function recovery is achieved.

Continuous Renal Replacement Therapy (CRRT) is a crucial treatment for ICU patients with acute renal failure. It offers continuous toxin removal and prevents fluid accumulation in the patient's body. The therapy not only eliminates toxins but also physiological substances, including micronutrients and essential elements for cellular metabolism and organ function.

Currently, there is limited information available to adjust the renal therapy dose and avoid or balance the loss of these substances without causing toxin accumulation. Some studies suggest that high doses of therapy do not provide benefits and increase complications.

The objective of this study is to evaluate two doses of continuous renal therapy in terms of internal environment control (sodium, potassium, and acids and bases), micronutrient loss, and toxin elimination. After 48 hours of therapy, patients will be assigned to continue with a dose equal to the initial dose or a decrease in the initial dose. These two options are part of the current standard practice in our center.

Patients participating in the study will be randomly assigned one of the continuous renal therapy doses. The study is open, so treating physicians will always know the therapy the patient is receiving and can freely adjust it if deemed necessary.

The intervention duration is 96 hours, after which the dose will be at the discretion of the treating medical team. A follow-up will be conducted through medical records or phone calls approximately 90 days after starting therapy.

The risks for the patient are minimal, as toxin elimination monitoring will be even more intensive than usual. The study plans to include approximately 100 patients.

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Detailed Description

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Conditions

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Renal Replacement Therapy for Acute Kidney Injury in ICU Continuous Renal Replacement Therapy (CRRT)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective comparative intervention study, Single-center. Randomized, open-label study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Statistical analysis

Study Groups

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Intervention

Effluent dose schedule of 10-20 ml/kg/h after 48 hours of starting dose of 25-35 ml/kg/h, until completing 96 hours

Group Type EXPERIMENTAL

continuous renal replacement therapy

Intervention Type PROCEDURE

Intervention Arm: Effluent dose schedule of 10-20 ml/kg/h after 48 hours of starting dose of 25-35 ml/kg/h, until completing 96 hours

Control Arm Effluent dosage schedule of 25-35 ml/kg/h fixed for 96 hours

Control

Effluent dosage schedule of 25-35 ml/kg/h fixed for 96 hours

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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continuous renal replacement therapy

Intervention Arm: Effluent dose schedule of 10-20 ml/kg/h after 48 hours of starting dose of 25-35 ml/kg/h, until completing 96 hours

Control Arm Effluent dosage schedule of 25-35 ml/kg/h fixed for 96 hours

Intervention Type PROCEDURE

Other Intervention Names

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continuous renal replacement dose

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years of age or older
* Acute renal failure (AKIN 3) requiring Continuous Renal Replacement Therapy
* Requirement of vasoactive drugs (norepinephrine \> 0.1 mcg/kg/min)
* Written informed consent (patient or family)

Exclusion Criteria

* Lack of informed consent.
* Possibility of using plasma exchange or MARS therapy at the at the time of inclusion.
* Baseline renal function with an estimated glomerular filtration rate (CKD-EPI) less than 30 ml/min.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No