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

Simplified Regional Citrate Anticoagulation Protocols for CVVH, CVVHDF and SLED Focused on the Prevention of RRT-related Hypophosphatemia and Optimization of Acid-base Balance: a Pilot Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03976440
Enrollment
30
Registered
2019-06-06
Start date
2019-06-01
Completion date
2021-01-31
Last updated
2019-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure, Dialysis Related Complication, Hypomagnesemia, Hypophosphatemia

Keywords

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

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.

Detailed description

The need for continuous anticoagulation represents a potential drawback of RRT modalities. KDIGO 2012 guidelines on acute kidney injury (AKI) suggest the adoption of RCA as first choice anticoagulation modality for continuous RRT (CRRT) in patients without contraindications for citrate. Citrate has been also introduced as anticoagulant for SLED and its use in the context of a mainly diffusive prolonged intermittent modality has been shown to represent an easy and safe method to maintain the extracorporeal circuit when concentrated citrate solutions, such as ACD-A are used. Hypophosphatemia is a known issue of RRT, and has been reported in up to 50-80% of cases when standard RRT solutions are used, especially in continuous/prolonged intermitted modalities when high RRT doses are delivered. RRT-related phosphate depletion should be avoided in critically ill patients due to the relevant hypophosphatemia-associated complications in this clinical setting. The adoption of phosphate-containing CRRT solutions could reduce the incidence of hypophosphatemia and minimize the need for parenteral phosphorus supplementation.The adoption of a commercially available phosphate-containing CRRT solution, in the setting of RCA-RRT may allow to meet the double target of minimizing RRT-induced hypophosphatemia and ensuring an adequate circuit life, also avoiding electrolyte and acid-base derangements.

Interventions

OTHERRenal Replacement Therapy (RRT) start

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

Sponsors

University of Parma
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* age \< 18 years

Design outcomes

Primary

MeasureTime frameDescription
Hypophosphatemia72 hoursOccurrence of hypophosphatemia during the first 72 hours of continuous renal replacement therapy (CRRT) or sustained low-efficiency dialysis (SLED)
Acid-base derangements72 hoursOccurrence of acid-base derangements during CRRT and SLED using a simplified RCA protocol
Variations of RCA-RRT parameters72 hoursEvaluation of the need for variations of RCA-RRT dialysis parameters from initial RRT settings
Variations of RCA-RRT solutions72 hoursEvaluation of the need for variations in RRT solutions flow rate rom initial RRT settings

Secondary

MeasureTime frameDescription
Hypomagnesemia72 hoursOccurrence of hypomagnesemia during the first 72 hours of CRRT or SLED
Efficacy of RCA72 hoursEfficacy of RCA in terms of circuit lifetime and filter efficiency

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026