Validation of a Regional Citrate Anticoagulation Protocol in Critically Ill Patients on Continuous Renal Replacement Therapy (CRRT)

April 1, 2026 updated by: Ana Jiménez Valenzuela, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

The objective of this study is to evaluate the effectiveness of a modified continuous renal replacement therapy (CRRT) protocol in maintaining electrolyte balance in adult patients with acute kidney injury (AKI) admitted to the intensive care unit (ICU).

The study assesses whether the use of continuous venovenous hemodiafiltration (CVVHDF) with post-filter replacement under citrate anticoagulation reduces electrolyte losses and the need for electrolyte supplementation compared with standard dialytic CRRT.

Participants receiving standard CRRT will be compared with those treated with the modified protocol.

The duration of participation corresponds to the period during which CRRT is required. Data collection will cease once CRRT is discontinued.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Electrolyte disturbances are common in patients undergoing continuous renal replacement therapy (CRRT) with regional citrate anticoagulation due to significant electrolyte losses during treatment. These alterations may lead to clinically relevant complications and increased need for electrolyte supplementation.

This study evaluates a modified CRRT protocol combining diffusive and convective modalities with post-filter replacement, aiming to improve electrolyte balance and reduce electrolyte supplementation requirements.

The primary objective is to assess whether continuous venovenous hemodiafiltration (CVVHDF) with post-filter replacement reduces the need for electrolyte supplementation compared with standard continuous venovenous hemodialysis (CVVHD) in patients with acute kidney injury.

This is a non-randomized interventional study with sequential assignment comparing a prospective cohort treated with the modified CRRT protocol and a historical control cohort treated with standard dialytic CRRT.

The study population includes adult patients (≥18 years) admitted to the multidisciplinary ICU of Hospital de la Santa Creu i Sant Pau with a diagnosis of acute kidney injury requiring CRRT.

Study Type

Interventional

Enrollment (Estimated)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Alejandra Espinosa Guerrero, Clinical Operations Head
  • Phone Number: 7796 +34 935537796
  • Email: uicec@santpau.cat

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08041
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
        • Contact:
          • Alejandra Espinosa, Clinical Operations Head
          • Phone Number: 7796 +34935537796
          • Email: uicec@santpau.cat
        • Principal Investigator:
          • Ana Jiménez Valenzuela, Nurse
        • Sub-Investigator:
          • Antoni Jordi Betbesé Roig, Clinical Head of the ICU
        • Sub-Investigator:
          • Almudena Mateos Dávila, Doctor of Nursing and Health
        • Sub-Investigator:
          • Ariadna González Ybarra, Nurse
        • Sub-Investigator:
          • Ariadna Pérez Rodriguez, Nurse
        • Sub-Investigator:
          • Víctor Guerrero Cruz, Nurse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Age ≥18 years
  • Admission to the intensive care unit (ICU)
  • Diagnosis of acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT)
  • Use of regional citrate anticoagulation during CRRT Exclusion Criteria
  • Known allergy or intolerance to citrate
  • Contraindications to citrate anticoagulation (e.g., severe liver failure or severe metabolic disorders affecting citrate metabolism)
  • Pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CVVHD (Historical Control)
Historical control cohort of patients treated with continuous venovenous hemodialysis (CVVHD) with regional citrate anticoagulation between 2019 and 2021 in the intensive care unit (ICU) of Hospital de la Santa Creu i Sant Pau.
Procedure: continuous renal replacement therapy
Continuous renal replacement therapy (CRRT) using regional citrate anticoagulation. Treatment modalities include continuous venovenous hemodialysis (CVVHD) and continuous venovenous hemodiafiltration (CVVHDF) with post-filter replacement, depending on study group assignment.
Other Names:
  • CVVHD
  • CVVHDF
Experimental: CVVHDF with Post-Filter Replacement
Prospective cohort of patients treated with continuous venovenous hemodiafiltration (CVVHDF) with post-filter replacement under regional citrate anticoagulation. Patients admitted to the ICU of Hospital de la Santa Creu i Sant Pau from November 2024 onwards who require continuous renal replacement therapy (CRRT) will be included.
Procedure: continuous renal replacement therapy
Continuous renal replacement therapy (CRRT) using regional citrate anticoagulation. Treatment modalities include continuous venovenous hemodialysis (CVVHD) and continuous venovenous hemodiafiltration (CVVHDF) with post-filter replacement, depending on study group assignment.
Other Names:
  • CVVHD
  • CVVHDF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total electrolyte supplementation during CRRT
Time Frame: From CRRT initiation through CRRT discontinuation, up to 14 days
Total amount of electrolyte supplementation administered during continuous renal replacement therapy (CRRT), including potassium, magnesium, and phosphate, expressed as total mmol administered per day (mmol/day)
From CRRT initiation through CRRT discontinuation, up to 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRRT circuit lifespan (hours)
Time Frame: Assessed for each CRRT circuit from CRRT initiation through CRRT discontinuation, up to 7 days per circuit
Duration of each CRRT circuit, defined as the total time in hours that the extracorporeal circuit remains functional before replacement.
Assessed for each CRRT circuit from CRRT initiation through CRRT discontinuation, up to 7 days per circuit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

  • Study Director: Alejandra Espinosa Guerrero, Clinical Operations Head, Fundació de Gestió Sanitarària de l'Hospital de la Santa Creu i Sant Pau de Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 8, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-CIT-2024-81

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional data protection policies and the sensitive nature of patient data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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