NCT07514650

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-24
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: Spain