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

NCT ID: NCT02194569

Last Updated: 2018-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-06-30

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.

Conditions

Critically Ill; Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

High citrate group

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.

Group Type: EXPERIMENTAL

Citrate

Intervention Type: DRUG

Low citrate group

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.

Group Type: EXPERIMENTAL

Citrate

Intervention Type: DRUG

Interventions

Citrate

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: lead

Responsible Party

Willem Boer

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Willem Boer, MD

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

Ziekenhuis Oost Limburg

Genk, Limburg, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 34895160 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33314078 (View on PubMed)

Other Identifiers

CIDOUT

Identifier Type: -

Identifier Source: org_study_id