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Continuous Renal Replacement Therapy Doses in Critically Ill Patients With Acute Kidney Injury (CRRIT1)

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Fundacion Clinic per a la Recerca Biomédica

Status

Not yet enrolling

Conditions

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

Treatments

Procedure: continuous renal replacement therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06901011
HCB/2024/0228

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Intervention
Experimental group
Description:
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
Treatment:
Procedure: continuous renal replacement therapy
Control
No Intervention group
Description:
Effluent dosage schedule of 25-35 ml/kg/h fixed for 96 hours

Trial contacts and locations

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Central trial contact

Enric Reverter, MD, PhD; Gaston J Piñeiro, MD, PhD

Data sourced from clinicaltrials.gov

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