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

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ClinicalTrials.gov Identifier: NCT03976440
Recruitment Status : Unknown
Verified June 2019 by Enrico Fiaccadori, University of Parma.
Recruitment status was:  Active, not recruiting
First Posted : June 6, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Enrico Fiaccadori, University of Parma

Study Description
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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.

Condition or disease Intervention/treatment
Acute Renal Failure Dialysis Related Complication Hypophosphatemia Hypomagnesemia Other: Renal Replacement Therapy (RRT) start

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 Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : June 1, 2019
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Renal 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

Outcome Measures
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Primary Outcome Measures :
  1. Hypophosphatemia [ Time Frame: 72 hours ]
    Occurrence of hypophosphatemia during the first 72 hours of continuous renal replacement therapy (CRRT) or sustained low-efficiency dialysis (SLED)

  2. Acid-base derangements [ Time Frame: 72 hours ]
    Occurrence of acid-base derangements during CRRT and SLED using a simplified RCA protocol

  3. Variations of RCA-RRT parameters [ Time Frame: 72 hours ]
    Evaluation of the need for variations of RCA-RRT dialysis parameters from initial RRT settings

  4. Variations of RCA-RRT solutions [ Time Frame: 72 hours ]
    Evaluation of the need for variations in RRT solutions flow rate rom initial RRT settings


Secondary Outcome Measures :
  1. Hypomagnesemia [ Time Frame: 72 hours ]
    Occurrence of hypomagnesemia during the first 72 hours of CRRT or SLED

  2. Efficacy of RCA [ Time Frame: 72 hours ]
    Efficacy of RCA in terms of circuit lifetime and filter efficiency


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)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976440


Locations
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Italy
University of Parma - UO Nefrologia AOU
Parma, Italy
Sponsors and Collaborators
University of Parma
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Enrico Fiaccadori, University Professor, University of Parma
ClinicalTrials.gov Identifier: NCT03976440    
Other Study ID Numbers: CRRT/SLED-RCA protocol
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enrico Fiaccadori, University of Parma:
Acute kidney injury
Regional citrate anticoagulation
Continuous renal replacement therapy
Prolonged intermittent renal replacement therapy
Additional relevant MeSH terms:
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Acute Kidney Injury
Hypophosphatemia
Renal Insufficiency
Kidney Diseases
 Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases