Simplified Regional Citrate Anticoagulation Protocols for CVVH, CVVHDF and SLED: a Pilot Study

NCT03976440 | Unknown

• 1 other identifier: CRRT/SLED-RCA protocol
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study are: 1) To evaluate the occurrence of acid-base alterations and the incidence of hypophosphatemia during different modalities of Renal Replacement Terapy (RRT) in critically ill patients \[CVVH, CVVHDF and SLED (Sustained Low-Efficiency Dialysis)\] by using a simplified Regional Citrate Anticoagulation (RCA) protocol combined with the adoption of a phosphate-containing solution as dialysate and/or replacement fluid; 2) To optimize the infusion rates of different solutions adopted, including citrate, in order to obtain an appropriate electrolyte and buffer supply. The final aim of this approach will be to reduce the need for frequent monitoring of acid-base status and electrolytes (with special regard to ionized calcium levels), and to avoid the need for frequent adjustments of RCA-RRT parameters (infusion rate of different solutions, electrolytes supplementation in the course of RRT). This approach could allow to simplify anticoagulation protocols with citrate, in order to minimize potential concerns hampering a wider diffusion of RCA in daily practice.

Conditions

Acute Renal Failure; Dialysis Related Complication; Hypophosphatemia; Hypomagnesemia

Keywords

Acute kidney injury; Regional citrate anticoagulation; Continuous renal replacement therapy; Prolonged intermittent renal replacement therapy

Outcome Measures

Primary Outcomes (4)

• Hypophosphatemia

  Occurrence of hypophosphatemia during the first 72 hours of continuous renal replacement therapy (CRRT) or sustained low-efficiency dialysis (SLED)

  72 hours

• Acid-base derangements

  Occurrence of acid-base derangements during CRRT and SLED using a simplified RCA protocol

  72 hours

• Variations of RCA-RRT parameters

  Evaluation of the need for variations of RCA-RRT dialysis parameters from initial RRT settings

  72 hours

• Variations of RCA-RRT solutions

  Evaluation of the need for variations in RRT solutions flow rate rom initial RRT settings

  72 hours

Secondary Outcomes (2)

• Hypomagnesemia

  72 hours

• Efficacy of RCA

  72 hours

Interventions

Renal Replacement Therapy (RRT) start OTHER

At the discretion of the nephrologist, treatment modality will be selected among CVVH, CVVHDF or SLED. Whatever the RRT modality, the investigators will adopt RCA as the standard anticoagulation strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients aged \>=18 years with severe acute kidney injury (AKI) or end stage renal disease (ESRD) requiring renal replacement therapy

You may qualify if:

• age \>= 18 years
• critically ill patients requiring continuous or prolonged intermittent renal replacement therapy for severe acute kidney injury (AKI)
• critically ill patients requiring continuous or prolonged intermittent renal replacement therapy for end stage renal disease (ESRD)

You may not qualify if:

• age \< 18 years

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

University of Parma - UO Nefrologia AOU

Parma, Italy

Location

Related Publications (54)

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• Pistolesi V, Zeppilli L, Polistena F, Sacco MI, Pierucci A, Tritapepe L, Regolisti G, Fiaccadori E, Morabito S. Preventing Continuous Renal Replacement Therapy-Induced Hypophosphatemia: An Extended Clinical Experience with a Phosphate-Containing Solution in the Setting of Regional Citrate Anticoagulation. Blood Purif. 2017;44(1):8-15. doi: 10.1159/000453443. Epub 2017 Feb 21.

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• Di Mario F, Sabatino A, Regolisti G, Pacchiarini MC, Greco P, Maccari C, Vizzini G, Italiano C, Pistolesi V, Morabito S, Fiaccadori E. Simplified regional citrate anticoagulation protocol for CVVH, CVVHDF and SLED focused on the prevention of KRT-related hypophosphatemia while optimizing acid-base balance. Nephrol Dial Transplant. 2023 Sep 29;38(10):2298-2309. doi: 10.1093/ndt/gfad068.

  PMID: 37037771 DERIVED

Related Links

• KDIGO Clinical Practice Guideline for Acute Kidney Injury

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples to determine the citrate concentration in course of renal replacement therapy (RRT) in the setting of regional citrate anticoagulation (RCA)

MeSH Terms

Conditions

Acute Kidney Injury; Hypophosphatemia

Interventions

Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 6, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2019
• Study Completion: January 31, 2021
• Last Updated: July 24, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)