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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Total electrolyte supplementation during CRRT [Срок оценки: From CRRT initiation through CRRT discontinuation, up to 14 days]

Вторичные конечные точки (1)

• CRRT circuit lifespan (hours) [Срок оценки: Assessed for each CRRT circuit from CRRT initiation through CRRT discontinuation, up to 7 days per circuit]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital de la Santa Creu i Sant Pau — Barcelona

Публикации

• Morabito S, Pistolesi V, Tritapepe L, Vitaliano E, Zeppilli L, Polistena F, Fiaccadori E, Pierucci A. Continuous venovenous hemodiafiltration with a low citrate dose regional anticoagulation protocol and a phosphate-containing solution: effects on acid-base status and phosphate supplementation needs. BMC Nephrol. 2013 Oct 25;14:232. doi: 10.1186/1471-2369-14-232. PMID 24156306
• Di Mario F, Regolisti G, Greco P, Maccari C, Superchi E, Morabito S, Pistolesi V, Fiaccadori E. Prevention of hypomagnesemia in critically ill patients with acute kidney injury on continuous kidney replacement therapy: the role of early supplementation and close monitoring. J Nephrol. 2021 Aug;34(4):1271-1279. doi: 10.1007/s40620-020-00864-4. Epub 2020 Oct 1. PMID 33001413
• Jacobs R, Verbrugghe W, Dams K, Roelant E, Couttenye MM, Devroey D, Jorens P. Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy: Is Metabolic Fear the Enemy of Logic? A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Life (Basel). 2023 May 17;13(5):1198. doi: 10.3390/life13051198. PMID 37240843
• Datzmann T, Trager K, Reinelt H, von Freyberg P. Elimination Rates of Electrolytes, Vitamins, and Trace Elements during Continuous Renal Replacement Therapy with Citrate Continuous Veno-Venous Hemodialysis: Influence of Filter Lifetime. Blood Purif. 2017;44(3):210-216. doi: 10.1159/000477454. Epub 2017 Aug 9. PMID 28787723
• Jeffrey YH, Hoi-Ping S, Kit Hung AL, Chung-Ling L, Wing-Wa Y, King-Yiu L. Experiences with Continuous Venovenous Hemofiltration using 18mmol/L predilution Citrate anticoagulation and a Phosphate Containing Replacement Solution. Indian J Crit Care Med. 2017 Jan;21(1):11-16. doi: 10.4103/0972-5229.198311. PMID 28197045
• Morabito S, Pistolesi V, Tritapepe L, Zeppilli L, Polistena F, Fiaccadori E, Pierucci A. Regional citrate anticoagulation in CVVH: a new protocol combining citrate solution with a phosphate-containing replacement fluid. Hemodial Int. 2013 Apr;17(2):313-20. doi: 10.1111/j.1542-4758.2012.00730.x. Epub 2012 Aug 7. PMID 22882732
• Zarbock A, Kullmar M, Kindgen-Milles D, Wempe C, Gerss J, Brandenburger T, Dimski T, Tyczynski B, Jahn M, Mulling N, Mehrlander M, Rosenberger P, Marx G, Simon TP, Jaschinski U, Deetjen P, Putensen C, Schewe JC, Kluge S, Jarczak D, Slowinski T, Bodenstein M, Meybohm P, Wirtz S, Moerer O, Kortgen A, Simon P, Bagshaw SM, Kellum JA, Meersch M; RICH Investigators and the Sepnet Trial Group. Effect of PMID 33095849
• Gould DW, Doidge J, Sadique MZ, Borthwick M, Hatch R, Caskey FJ, Forni L, Lawrence RF, MacEwen C, Ostermann M, Mouncey PR, Harrison DA, Rowan KM, Young JD, Watkinson PJ. Heparin versus citrate anticoagulation for continuous renal replacement therapy in intensive care: the RRAM observational study. Health Technol Assess. 2022 Feb;26(13):1-58. doi: 10.3310/ZXHI9396. PMID 35212260

Идентификаторы

NCT: NCT07514650 · IIBSP-CIT-2024-81

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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