Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVVHD (Historical Control) | Active Comparator | 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. |
|
| CVVHDF with Post-Filter Replacement | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous renal replacement therapy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From CRRT initiation through CRRT discontinuation, up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| CRRT circuit lifespan (hours) | Duration of each CRRT circuit, defined as the total time in hours that the extracorporeal circuit remains functional before replacement. | Assessed for each CRRT circuit from CRRT initiation through CRRT discontinuation, up to 7 days per circuit |
Not provided
Inclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Jiménez Valenzuela, Nurse | Contact | +34935537796 | ajimenezva@santpau.cat | |
| Alejandra Espinosa Guerrero, Clinical Operations Head | Contact | +34 935537796 | 7796 | uicec@santpau.cat |
| Name | Affiliation | Role |
|---|---|---|
| Alejandra Espinosa Guerrero, Clinical Operations Head | Fundació de Gestió Sanitarària de l'Hospital de la Santa Creu i Sant Pau de Barcelona | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Barcelona | 08041 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24156306 | Background | 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. | |
| 33001413 |
Not provided
Not provided
Individual participant data will not be shared due to institutional data protection policies and the sensitive nature of patient data.
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
|
| 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. |
| 37240843 | Background | 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. |
| 28787723 | Background | 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. |
| 28197045 | Background | 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. |
| 22882732 | Background | 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. |
| 33095849 | Background | 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 Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation During Continuous Kidney Replacement Therapy on Dialysis Filter Life Span and Mortality Among Critically Ill Patients With Acute Kidney Injury: A Randomized Clinical Trial. JAMA. 2020 Oct 27;324(16):1629-1639. doi: 10.1001/jama.2020.18618. |
| 35212260 | Background | 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. |
| 37897131 | Background | Mateos-Davila A, Betbese Roig AJ, Santos Rodriguez JA, Guix-Comellas EM. Comparison of diluted vs concentrated regional citrate anticoagulation in continuous renal replacement therapy: A quasi-experimental study. Nurs Crit Care. 2024 Sep;29(5):1005-1014. doi: 10.1111/nicc.12991. Epub 2023 Oct 27. |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000079664 | Continuous Renal Replacement Therapy |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided