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

• Conditions: Acute Renal Failure; Dialysis Related Complication; Hypomagnesemia; Hypophosphatemia

• Registration Number: NCT03976440
• Lead Sponsor: University of Parma

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.

Study Timeline

• Study First Submitted: 2019-05-29
• Status Verified: 2019-06
• Study Start: 2019-06-01
• Primary Completion: 2019-06-01
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-06
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hypophosphatemia	72 hours	Occurrence of hypophosphatemia during the first 72 hours of continuous renal replacement therapy (CRRT) or sustained low-efficiency dialysis (SLED)
Variations of RCA-RRT solutions	72 hours	Evaluation of the need for variations in RRT solutions flow rate rom initial RRT settings
Acid-base derangements	72 hours	Occurrence of acid-base derangements during CRRT and SLED using a simplified RCA protocol
Variations of RCA-RRT parameters	72 hours	Evaluation of the need for variations of RCA-RRT dialysis parameters from initial RRT settings

Secondary Outcome Measures

Name	Time	Method
Efficacy of RCA	72 hours	Efficacy of RCA in terms of circuit lifetime and filter efficiency
Hypomagnesemia	72 hours	Occurrence of hypomagnesemia during the first 72 hours of CRRT or SLED

Trial Locations

Locations (1)

University of Parma - UO Nefrologia AOU; 🇮🇹 Parma, Italy