Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06901011

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Renal Replacement Therapy

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

Other names: continuous renal replacement dose

Primary outcomes

  1. Control of biochemical parameters (natremia, kalemia, and base excess)

    Time frame: From enrollment to the end of follow-up at 90 days

    To compare the impact of a reduced dose of effluent regimen in CRRT (10-20 ml/kg/h), after 48 hours of 25-35 ml/kg/h dose, on the control of internal homeostasis parameters (Natremia, kalemia and base excess) compared to a fixed dose of 25-35 ml/kg/h for 96 hours of CRRT.

Study contacts

Contact information is provided by the study sponsor or research team.

Enric Reverter, MD, PhD

CONTACT

[email protected]

+34932275400

Gaston J Piñeiro, MD, PhD

CONTACT

[email protected]

+34932275400 ext. 5400 / 3474

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Collaborators

  • Hospital Clinic of Barcelona

Registry information

Acronym: CRRIT1

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 28, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.