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OpenTrials
Completed

NCT Number: NCT02194569

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citrate

Drug

Primary outcomes

  1. Mg balance of CVVH treatment

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 18, 2014
Registry last updated
Apr 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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