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NCT Number: NCT07514650

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location status: Recruiting

Location contact

Alejandra Espinosa, Clinical Operations Head

CONTACT

[email protected]

+34935537796 ext. 7796

Almudena Mateos Dávila, Doctor of Nursing and Health

SUB_INVESTIGATOR

Ana Jiménez Valenzuela, Nurse

CONTACT

[email protected]

+34662172345

Ana Jiménez Valenzuela, Nurse

PRINCIPAL_INVESTIGATOR

Antoni Jordi Betbesé Roig, Clinical Head of the ICU

SUB_INVESTIGATOR

Ariadna González Ybarra, Nurse

SUB_INVESTIGATOR

Ariadna Pérez Rodriguez, Nurse

SUB_INVESTIGATOR

Víctor Guerrero Cruz, Nurse

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Continuous Renal Replacement Therapy

Procedure

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: CVVHDF, CVVHD

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

Study contacts

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

Alejandra Espinosa Guerrero, Clinical Operations Head

CONTACT

[email protected]

+34 935537796 ext. 7796

Ana Jiménez Valenzuela, Nurse

CONTACT

[email protected]

+34935537796

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: CRRT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

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.

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