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

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

Status: Enrolling

Conditions: Acute Kidney Injury; ICU Patients; Electrolytes; Continuous Renal Replacement Therapy (CRRT)

Treatments: Procedure: continuous renal replacement therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07514650

IIBSP-CIT-2024-81

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

CVVHD (Historical Control)

Active Comparator group

Description:

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.

Treatment:

Procedure: continuous renal replacement therapy

CVVHDF with Post-Filter Replacement

Experimental group

Description:

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.

Treatment:

Procedure: continuous renal replacement therapy