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Magnesium Balance of Citrate-based Continuous Venovenous Hemofiltration, Effect of Citrate Dose.

Primary Purpose

Critically Ill, Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Citrate
Sponsored by
Ziekenhuis Oost-Limburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critically Ill

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Critically ill patients requiring CRRT for AKI (RIFLE criteria)
  • Written informed consent from the patient or legal representative

Exclusion Criteria:

  • pre-existing chronic renal insufficiency requiring dialysis
  • chronic immunosuppression
  • liver cirrhosis Child-Pugh C
  • severe or shock-related hepatitis
  • Pregnancy

Sites / Locations

  • Ziekenhuis Oost Limburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High citrate group

Low citrate group

Arm Description

Blood flow according to weight.Target citrate concentration is 4,5 mmol/L blood flow delivered as prismocitrate 18/0 pre-filter. After correction for filtration fraction, the required further amount of substitution fluid is given post filter to achieve a hemofiltration rate of 30 ml/kg/hr. Blood citrate concentrations are tailored to achieve an iCa of 0.8-1.1 mg/dL.

Blood flow according to weight. Target citrate concentration is 2.5 mmol/L blood flow delivered as prismocitrate 18/0 pre-filter. After correction for filtration fraction, the required further amount of substitution fluid is given post filter to achieve a hemofiltration rate of 30 ml/kg/hr. Blood citrate concentrations are tailored to achieve an iCa of 1.3-1.6 mg/dL.

Outcomes

Primary Outcome Measures

Mg balance of CVVH treatment

Secondary Outcome Measures

Full Information

First Posted
July 16, 2014
Last Updated
March 29, 2018
Sponsor
Ziekenhuis Oost-Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT02194569
Brief Title
Magnesium Balance of Citrate-based Continuous Venovenous Hemofiltration, Effect of Citrate Dose.
Official Title
Magnesium Balance of Citrate-based Continuous Venovenous Hemofiltration, Effect of Citrate Dose.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziekenhuis Oost-Limburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Rationale: A higher citrate dose during continuous venovenous hemofiltration provides better anticoagulation but possibly a higher risk of citrate accumulation in case of metabolic limitations. A higher citrate dose also increases magnesium loss in ultrafiltrate, while a negative magnesium balance is unwanted. Objective: Aim of this study is to determine the magnesium balance of citrate-based continuous veno-venous hemofiltration (CVVH) and to determine whether and to which extent the magnesium balance depends on citrate dose. Study design and methods: A prospective randomized study conducted in critically ill patients with acute kidney injury (AKI), treated with CVVH, with either low dose citrate (2.5 mmol/L blood flow in the filter) or high dose citrate (4.5 mmol/L blood flow in the filter) as anti-coagulant, targeting a postfilter ionized Calcium (iCa) of resp. 1.3-1.6 mg/dL (0.325-0.4 mmol/L) and 0.8-1.1 mg/dL (0.2-0.275 mmol/L). Post-filter blood as well as effluent aliquots and bloodconcentrations in the patient are tested for the following variables: (0 , 2 , 4, 6, 12 and 24 hrs): Total Magnesium (tMg) and total Calcium (tCa), ionized Ca (iCa)(bloodgas analyzer). In addition, hematocrit, albumin, total protein, ureum and creatinine and parathormone (PTH) are determined in arterial blood at 0 and 24 hrs or at the time of protocol exit and citrate concentrations in postfilter and arterial blood at 1 and 24 hrs or at protocol exit. Sample sites: arterial line, postfilter port (after postdilution and calcium compensation), effluent sample. All flow rates to be noted. Study population: Twenty patients admitted to intensive care, requiring continuous renal replacement therapy (CRRT) for AKI. Intervention: Anti-coagulation with either low dose citraat (2.5 mmol/L blood flow) or high dose citraat (4.5 mmol/L blood flow) targeting postfilter iCa of resp. 1.3-1.6 and 0.8-1.1 mg/dL. Both regimens are within standard protocolled CVVH treatment in the intensive care department.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill, Acute Kidney Injury

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High citrate group
Arm Type
Experimental
Arm Description
Blood flow according to weight.Target citrate concentration is 4,5 mmol/L blood flow delivered as prismocitrate 18/0 pre-filter. After correction for filtration fraction, the required further amount of substitution fluid is given post filter to achieve a hemofiltration rate of 30 ml/kg/hr. Blood citrate concentrations are tailored to achieve an iCa of 0.8-1.1 mg/dL.
Arm Title
Low citrate group
Arm Type
Experimental
Arm Description
Blood flow according to weight. Target citrate concentration is 2.5 mmol/L blood flow delivered as prismocitrate 18/0 pre-filter. After correction for filtration fraction, the required further amount of substitution fluid is given post filter to achieve a hemofiltration rate of 30 ml/kg/hr. Blood citrate concentrations are tailored to achieve an iCa of 1.3-1.6 mg/dL.
Intervention Type
Drug
Intervention Name(s)
Citrate
Primary Outcome Measure Information:
Title
Mg balance of CVVH treatment
Time Frame
1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Critically ill patients requiring CRRT for AKI (RIFLE criteria) Written informed consent from the patient or legal representative Exclusion Criteria: pre-existing chronic renal insufficiency requiring dialysis chronic immunosuppression liver cirrhosis Child-Pugh C severe or shock-related hepatitis Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willem Boer, MD
Organizational Affiliation
Ziekenhuis Oost-Limburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
34895160
Citation
Boer W, Fivez T, Vander Laenen M, Bruckers L, Gron HJ, Schetz M, Oudemans-van Straaten H. Citrate dose for continuous hemofiltration: effect on calcium and magnesium balance, parathormone and vitamin D status, a randomized controlled trial. BMC Nephrol. 2021 Dec 11;22(1):409. doi: 10.1186/s12882-021-02598-2.
Results Reference
derived
PubMed Identifier
33314078
Citation
Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
Results Reference
derived

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Magnesium Balance of Citrate-based Continuous Venovenous Hemofiltration, Effect of Citrate Dose.

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