An observational study in Acute Renal Failure, Dialysis Related Complication and Hypophosphatemia, sponsored by University of Parma. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by University of Parma · Observational
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.
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.
1,594 studies on the registry are indexed under Acute Kidney Injury; 370 are open to participants now.
This study's planned enrollment of 30 is below the median of 151 across 772 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →University of Parma is the lead sponsor of 76 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Critically ill patients aged >=18 years with severe acute kidney injury (AKI) or end stage renal disease (ESRD) requiring renal replacement therapy
Exclusion Criteria:
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
Hypophosphatemia
Occurrence of hypophosphatemia during the first 72 hours of continuous renal replacement therapy (CRRT) or sustained low-efficiency dialysis (SLED)
Time frame: 72 hours
Acid-base derangements
Occurrence of acid-base derangements during CRRT and SLED using a simplified RCA protocol
Time frame: 72 hours
Variations of RCA-RRT parameters
Evaluation of the need for variations of RCA-RRT dialysis parameters from initial RRT settings
Time frame: 72 hours
Variations of RCA-RRT solutions
Evaluation of the need for variations in RRT solutions flow rate rom initial RRT settings
Time frame: 72 hours
Hypomagnesemia
Occurrence of hypomagnesemia during the first 72 hours of CRRT or SLED
Time frame: 72 hours
Efficacy of RCA
Efficacy of RCA in terms of circuit lifetime and filter efficiency
Time frame: 72 hours
Plan to share: No
This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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University of Parma