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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Sequential

Treatments tested in this trial

  • continuous renal replacement therapy

    Procedure/Surgery

    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.

Treatment groups

43 Participants
are divided into 2 treatment groups
Group A: CVVHD (Historical Control)Active comparator 1 intervention
Group B: CVVHDF with Post-Filter ReplacementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total electrolyte supplementation during CRRT

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)

Time frame
From CRRT initiation through CRRT discontinuation, up to 14 days

Secondary outcomes

1

CRRT circuit lifespan (hours)

Duration of each CRRT circuit, defined as the total time in hours that the extracorporeal circuit remains functional before replacement.

Time frame
Assessed for each CRRT circuit from CRRT initiation through CRRT discontinuation, up to 7 days per circuit

Other outcomes

Sponsors and contacts

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