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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07514650
Acronym
CRRT
Enrollment
43
Registered
2026-04-07
Start date
2024-11-24
Completion date
2026-11-01
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Continuous Renal Replacement Therapy (CRRT), Electrolytes, ICU Patients

Keywords

Regional Citrate Anticoagulation, Acute Kidney Injury, ICU patients, Continuous Renal Replacement Therapy, Diluted citrate, Electrolytes

Brief summary

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.

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.

Interventions

PROCEDUREcontinuous 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.

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This is a non-randomized interventional study with sequential assignment comparing a prospective cohort treated with a modified CRRT protocol including post-filter replacement with a historical control cohort treated with standard dialytic CRRT.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total electrolyte supplementation during CRRTFrom CRRT initiation through CRRT discontinuation, up to 14 daysTotal 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

MeasureTime frameDescription
CRRT circuit lifespan (hours)Assessed for each CRRT circuit from CRRT initiation through CRRT discontinuation, up to 7 days per circuitDuration of each CRRT circuit, defined as the total time in hours that the extracorporeal circuit remains functional before replacement.

Countries

Spain

Contacts

CONTACTAna Jiménez Valenzuela, Nurse
ajimenezva@santpau.cat+34935537796
CONTACTAlejandra Espinosa Guerrero, Clinical Operations Head
uicec@santpau.cat+34 935537796
STUDY_DIRECTORAlejandra Espinosa Guerrero, Clinical Operations Head

Fundació de Gestió Sanitarària de l'Hospital de la Santa Creu i Sant Pau de Barcelona

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026