Renal Replacement Therapy for Acute Kidney Injury in ICUCRRIT1NCT06901011
Continuous Renal Replacement Therapy Doses in Critically Ill Patients With Acute Kidney Injury
A study testing continuous renal replacement therapy in people with Renal Replacement Therapy for Acute Kidney Injury in ICU and Continuous Renal Replacement Therapy (CRRT), run by Fundacion Clinic per a la Recerca Biomédica.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Replacement Therapy for Acute Kidney Injury in ICU, Continuous Renal Replacement Therapy (CRRT)
- What is being tested?
- continuous renal replacement therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Renal Replacement Therapy for Acute Kidney Injury in ICU, Continuous Renal Replacement Therapy (CRRT)
- Being tested
- continuous renal replacement therapy
- Keywords
- Continuous Renal Replacement Therapy (CRRT), Renal Replacement Therapy for Acute Kidney Injury in ICU, dialytrauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous renal replacement therapyProcedure or surgery
Also called continuous renal replacement dose
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Procedure: continuous renal replacement therapy |
| Control | No intervention | Effluent dosage schedule of 25-35 ml/kg/h fixed for 96 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of biochemical parameters (natremia, kalemia, and base excess)
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.
Measured: From enrollment to the end of follow-up at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Aug 2025 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Renal Replacement Therapy for Acute Kidney Injury in ICUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective comparative intervention study, Single-center. Randomized, open-label study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Fritz Diekmann, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Gaston J Piñeiro, MD, PhD, Principal investigator, Hospital Clínic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901011
- Sponsor's protocol ID
- HCB/2024/0228
- Acronym
- CRRIT1
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The sharing of participants' individual data with third parties must be evaluated by the center's Research Ethics Committee. Collection of individual data may only be carried out within the parameters permitted by European data protection legislation.
Publications
Koekkoek KWA, Berger MM. An update on essential micronutrients in critical illness. Curr Opin Crit Care. 2023 Aug 1;29(4):315-329. doi: 10.1097/MCC.0000000000001062. Epub 2023 Jun 8.
PubMed 37306546Karkar A, Ronco C. Prescription of CRRT: a pathway to optimize therapy. Ann Intensive Care. 2020 Mar 6;10(1):32. doi: 10.1186/s13613-020-0648-y.
PubMed 32144519Fayad AI, Buamscha DG, Ciapponi A. Intensity of continuous renal replacement therapy for acute kidney injury. Cochrane Database Syst Rev. 2016 Oct 4;10(10):CD010613. doi: 10.1002/14651858.CD010613.pub2.
PubMed 27699760Jun M, Heerspink HJ, Ninomiya T, Gallagher M, Bellomo R, Myburgh J, Finfer S, Palevsky PM, Kellum JA, Perkovic V, Cass A. Intensities of renal replacement therapy in acute kidney injury: a systematic review and meta-analysis. Clin J Am Soc Nephrol. 2010 Jun;5(6):956-63. doi: 10.2215/CJN.09111209. Epub 2010 Apr 15.
PubMed 20395356RENAL Replacement Therapy Study Investigators; Bellomo R, Cass A, Cole L, Finfer S, Gallagher M, Lo S, McArthur C, McGuinness S, Myburgh J, Norton R, Scheinkestel C, Su S. Intensity of continuous renal-replacement therapy in critically ill patients. N Engl J Med. 2009 Oct 22;361(17):1627-38. doi: 10.1056/NEJMoa0902413.
PubMed 19846848Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
PubMed 26162677Maynar Moliner J, Honore PM, Sanchez-Izquierdo Riera JA, Herrera Gutierrez M, Spapen HD. Handling continuous renal replacement therapy-related adverse effects in intensive care unit patients: the dialytrauma concept. Blood Purif. 2012;34(2):177-85. doi: 10.1159/000342064. Epub 2012 Oct 24.
PubMed 23095418Chawla LS. Permissive azotemia during acute kidney injury enables more rapid renal recovery and less renal fibrosis: a hypothesis and clinical development plan. Crit Care. 2022 Apr 28;26(1):116. doi: 10.1186/s13054-022-03988-0.
PubMed 35484549
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Renal Replacement Therapy Doses in Critically Ill Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT06901011
- Acronym / sponsor ID
- CRRIT1 / HCB/2024/0228
- Conditions
- Renal Replacement Therapy for Acute Kidney Injury in ICU, Continuous Renal Replacement Therapy (CRRT)
- Keywords
- Continuous Renal Replacement Therapy (CRRT), Renal Replacement Therapy for Acute Kidney Injury in ICU, dialytrauma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective comparative intervention study, Single-center. Randomized, open-label study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: continuous renal replacement therapyEffluent 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 | No intervention | –Effluent dosage schedule of 25-35 ml/kg/h fixed for 96 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous renal replacement therapyAlso: continuous renal replacement doseIntervention 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 | Procedure or surgery | Intervention |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 37306546Koekkoek KWA, Berger MM. An update on essential micronutrients in critical illness. Curr Opin Crit Care. 2023 Aug 1;29(4):315-329. doi: 10.1097/MCC.0000000000001062. Epub 2023 Jun 8.
- Background: PubMed 32144519Karkar A, Ronco C. Prescription of CRRT: a pathway to optimize therapy. Ann Intensive Care. 2020 Mar 6;10(1):32. doi: 10.1186/s13613-020-0648-y.
- Background: PubMed 27699760Fayad AI, Buamscha DG, Ciapponi A. Intensity of continuous renal replacement therapy for acute kidney injury. Cochrane Database Syst Rev. 2016 Oct 4;10(10):CD010613. doi: 10.1002/14651858.CD010613.pub2.
- Background: PubMed 20395356Jun M, Heerspink HJ, Ninomiya T, Gallagher M, Bellomo R, Myburgh J, Finfer S, Palevsky PM, Kellum JA, Perkovic V, Cass A. Intensities of renal replacement therapy in acute kidney injury: a systematic review and meta-analysis. Clin J Am Soc Nephrol. 2010 Jun;5(6):956-63. doi: 10.2215/CJN.09111209. Epub 2010 Apr 15.
- Background: PubMed 19846848RENAL Replacement Therapy Study Investigators; Bellomo R, Cass A, Cole L, Finfer S, Gallagher M, Lo S, McArthur C, McGuinness S, Myburgh J, Norton R, Scheinkestel C, Su S. Intensity of continuous renal-replacement therapy in critically ill patients. N Engl J Med. 2009 Oct 22;361(17):1627-38. doi: 10.1056/NEJMoa0902413.
- Background: PubMed 26162677Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
- Background: PubMed 23095418Maynar Moliner J, Honore PM, Sanchez-Izquierdo Riera JA, Herrera Gutierrez M, Spapen HD. Handling continuous renal replacement therapy-related adverse effects in intensive care unit patients: the dialytrauma concept. Blood Purif. 2012;34(2):177-85. doi: 10.1159/000342064. Epub 2012 Oct 24.
- Background: PubMed 35484549Chawla LS. Permissive azotemia during acute kidney injury enables more rapid renal recovery and less renal fibrosis: a hypothesis and clinical development plan. Crit Care. 2022 Apr 28;26(1):116. doi: 10.1186/s13054-022-03988-0.
- Individual participant dataSharing planned: Undecided. The sharing of participants' individual data with third parties must be evaluated by the center's Research Ethics Committee. Collection of individual data may only be carried out within the parameters permitted by European data protection legislation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gaston J Piñeiro, MD, PhD principal investigator
Hospital Clínic of Barcelona
Questions about this trial
What is this clinical trial studying?
A study testing continuous renal replacement therapy in people with Renal Replacement Therapy for Acute Kidney Injury in ICU and Continuous Renal Replacement Therapy (CRRT), run by Fundacion Clinic per a la Recerca Biomédica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaston J Piñeiro, MD, PhD (+34932275400 ext. 5400 / 3474, GJPINEIR@CLINIC.CAT), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of biochemical parameters (natremia, kalemia, and base excess) (time frame: From enrollment to the end of follow-up at 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06901011, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.