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

July 23, 2019 updated by: Enrico Fiaccadori, University of Parma

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Parma, Italy
        • University of Parma - UO Nefrologia AOU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
72 hours
Acid-base derangements
Time Frame: 72 hours
Occurrence of acid-base derangements during CRRT and SLED using a simplified RCA protocol
72 hours
Variations of RCA-RRT parameters
Time Frame: 72 hours
Evaluation of the need for variations of RCA-RRT dialysis parameters from initial RRT settings
72 hours
Variations of RCA-RRT solutions
Time Frame: 72 hours
Evaluation of the need for variations in RRT solutions flow rate rom initial RRT settings
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypomagnesemia
Time Frame: 72 hours
Occurrence of hypomagnesemia during the first 72 hours of CRRT or SLED
72 hours
Efficacy of RCA
Time Frame: 72 hours
Efficacy of RCA in terms of circuit lifetime and filter efficiency
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Parma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

June 1, 2019

Study Completion (Anticipated)

January 31, 2021

Study Registration Dates

First Submitted

May 29, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRRT/SLED-RCA protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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