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RecruitingNCT07514650CRRTUpdated Apr 7, 2026

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

An interventional study of continuous renal replacement therapy in Acute Kidney Injury, ICU Patients and Continuous Renal Replacement Therapy (CRRT), sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Nov 2024, registered Mar 2026).
  • Started Nov 2024; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • Regional Citrate Anticoagulation
  • Acute Kidney Injury
  • ICU patients
  • Continuous Renal Replacement Therapy
  • Diluted citrate
  • Electrolytes
03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's planned enrollment of 43 is below the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
43 participants (estimated)

Study arms

  • Active comparator
    CVVHD (Historical Control)

    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.

    Procedure: continuous renal replacement therapy

  • Experimental
    CVVHDF with Post-Filter Replacement

    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.

    Procedure: continuous renal replacement therapy

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.

    Also known as: CVVHDF, CVVHD

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, Barcelona 08041, Spain
    • Ana Jiménez Valenzuela, Nurse · Contact · ajimenezva@santpau.cat · +34662172345
    • Alejandra Espinosa, Clinical Operations Head · Contact · uicec@santpau.cat · +34935537796
    • Ana Jiménez Valenzuela, Nurse · Principal investigator
    • Antoni Jordi Betbesé Roig, Clinical Head of the ICU · Sub investigator
    • Almudena Mateos Dávila, Doctor of Nursing and Health · Sub investigator
    • Ariadna González Ybarra, Nurse · Sub investigator
    • Ariadna Pérez Rodriguez, Nurse · Sub investigator
    • Víctor Guerrero Cruz, Nurse · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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 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. PubMed 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. PubMed 35212260 ↗
  • 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. PubMed 37897131 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared due to institutional data protection policies and the sensitive nature of patient data.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07514650
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible party
Ana Jiménez Valenzuela (Principal Investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau) — Principal investigator
First posted
Apr 7, 2026
Start date
Nov 24, 2024
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Apr 7, 2026

Study contacts

Ana Jiménez Valenzuela, Nurse
Contact
ajimenezva@santpau.cat
+34935537796
Alejandra Espinosa Guerrero, Clinical Operations Head
Contact
uicec@santpau.cat
+34 935537796 ext. 7796
Alejandra Espinosa Guerrero, Clinical Operations Head
study director · Fundació de Gestió Sanitarària de l'Hospital de la Santa Creu i Sant Pau de Barcelona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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