Effect of continuous slow renal replacement therapies in the treatment of acute kidney injury in critically ill patients.

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

ECO-LRA

Scientific title:

Effect of continuous slow renal replacement therapies in the treatment of acute kidney injury in critically ill patients.

Acronym of Scientific Title:

ECO-LRA

Secondary indentifying numbers:

ECO-LRA 202533

Issuing authority of the secondary identifying numbers:

Center for Medical-Surgical Research (CIMEQ)

Source(s) of monetary or material support:

Cuban Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Leanet

Midle name:

Maria

Last name:

Quiles Gomez

Medical Specialty :

Specialist of First Degree in Internal Medicine and of Second Degree in Intensive Care and Adult Emergencies.

Affiliation:

Center for Medical-Surgical Research (CIMEQ)

Postal address:

216th Street and 11B, Siboney, Playa.

City:

Havana

País:

Cuba

Zip Code:

Box 6096, Havana 6.

Telephone:

+53-78581000 ext. 511

Email address:

emihf@infomed.sld.cu [1]

leanetmariaq@gmail.com [2]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not Applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

29/05/2026

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Acute kidney injury in critically ill patients.

Health condition(s) code:

Acute Kidney Injury

Renal Insufficiency

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Intervention(s):

Group 1 (Experimental): Continuous slow renal replacement therapy (24 hours a day, 7 days a week) using the Prismaflex system will be used until renal function recovers and dialysis is no longer required. Group 2 (Control): Conventional dialysis will be used every other day or daily (2-3 hours) until renal function recovers and dialysis is no longer required.

Intervention code:

Dialysis

Continuous Renal Replacement Therapy

Intervention keyword:

Prismaflex System

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1. 28-day mortality (Proportion of patients who died within 28 days of starting renal replacement therapy). Measurement time: 28 days 2. Recovery of renal function (Proportion of patients who recover their urine output within 24 hours, normalize serum creatinine, and do not require dialysis therapy). Measurement time: At hospital discharge.

Key secondary outcomes:

1. PO2/FiO2 ratio (Ratio of arterial oxygen pressure to inspired oxygen fraction). Measurement time: At baseline and, on days 3, 7, 14 and 28. 2. Need for mechanical ventilation (Yes, No). Measurement time: At baseline and, on days 3, 7, 14 and 28. 3. Need for vasopressor support (Yes, No). Measurement time: At baseline and, on days 3, 7, 14 and 28. 4. Inflammatory mediators (Values of Procalcitonin, Interleukin 6, C-reactive protein). Measurement time: At baseline and, on days 3, 7, 14 and 28. 5. Clinical laboratory tests (Values of Creatinine, Urea, pH, Serum potassium, Bicarbonate, Hemoglobin, and Hematocrit). Measurement time: Daily until at hospital discharge.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1. Patients over 18 years of age 2. Acute kidney injury defined by AKIN criteria 2-3 3. Severe hyperkalemia refractory to conventional treatment. 4. Severe metabolic acidosis refractory to medical treatment. 5. Fluid overload with pulmonary edema refractory to diuretics. 6. Poisoning by dialyzable drugs or toxins.

Exclusion criteria:

1. Chronic kidney disease, presence of at least 2 previous plasma creatinine levels greater than 3 mg/dl (265 µmol/L) for more than 3 months or current dialysis treatment. 2. Patients with kidney transplantation. 3. Refusal of the patient or their family members or legal representative to participate in the study.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

N/A

Target sample size:

240

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Leanet

Middle Name:

Maria

Last Name:

Quiles Gomez

Specialty:

Specialist of First Degree in Internal Medicine and of Second Degree in Intensive Care and Adult Emergencies.

Affiliation:

Center for Medical-Surgical Research (CIMEQ)

Postal Address:

216th Street and 11B, Siboney, Playa.

City:

Havana

País:

Cuba

Zip Code:

Box 6096. Havana 6.

Telephone:

+537-8581000

Email :

emihf@infomed.sld.cu [1]

leanetmariaq@gmail.com [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Leanet

Middle Name:

Maria

Last Name:

Quiles Gomez

Specialty:

Specialist of First Degree in Internal Medicine and of Second Degree in Intensive Care and Adult Emergencies.

Affiliation:

Center for Medical-Surgical Research (CIMEQ)

Postal Address:

216th Street and 11B, Siboney, Playa.

City:

Havana

País:

Cuba

Zip Code:

Box 6096. Havana 6.

Telephone:

+53-78581000

Email :

emihf@infomed.sld.cu [1]

leanetmariaq@gmail.com [2]

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Center for Medical-Surgical Research (CIMEQ)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

19/09/2025

Postal address of Ethic Committee :

216th Street and 11B, Siboney, Playa. P.O. Box 6096, Havana 6. Havana, Cuba.

Telephone:

+53-72718424

Correo electrónico:

bcimeq@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

12/02/2028

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000476

Date of Registration in Primary Registry:

08/05/2026

Record Verification Date:

2026/05/08

Next update date:

2027/05/08

Link to the spanish version:

Click here [3]