Trial design: Computer guided normal-low versus normal-high potassium control in critically ill patients: Rationale of the GRIP-COMPASS study

BMC Anesthesiology

Study Protocol

Miriam Hoekstra¹  Joost MAA van der Maaten²  Mathijs Vogelzang³  Iwan CC van der Horst³  Felix Zijlstra³  Maarten WN Nijsten⁴  Farouq Ismael⁴  Annemieke Oude Lansink⁴ 

[1] Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700, Groningen, RB, The Netherlands;Department of Cardiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700, Groningen, RB, The Netherlands;Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700, Groningen, RB, The Netherlands;Department of Critical Care, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700, Groningen, RB, The Netherlands;Department of Cardiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700, Groningen, RB, The Netherlands;Department of Critical Care, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9700, Groningen, RB, The Netherlands;

关键词: Intensive Care Unit;    Intensive Care Unit Admission;    Intensive Care Unit Patient;    Potassium Level;    General Ward;   

DOI  :  10.1186/1471-2253-10-23

 received in 2010-06-08, accepted in 2010-12-31,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundPotassium depletion is common in hospitalized patients and can cause serious complications such as cardiac arrhythmias. In the intensive care unit (ICU) the majority of patients require potassium suppletion. However, there are no data regarding the optimal control target in critically ill patients. After open-heart surgery, patients have a strongly increased risk of atrial fibrillation or atrial flutter (AFF). In a novel trial design, we examined if in these patients different potassium control-targets within the normal range may have different effects on the incidence of AFF.Methods/DesignThe "computer-driven Glucose and potassium Regulation program in Intensive care Patients with COMparison of PotASSium targets within normokalemic range (GRIP-COMPASS) trial" is a single-center prospective trial in which a total of 1200 patients are assigned to either a potassium control-target of 4.0 mmol/L or 4.5 mmol/L in consecutive alternating blocks of 50 patients each. Potassium levels are regulated by the computer-assisted potassium suppletion algorithm called GRIP-II (Glucose and potassium regulation for Intensive care Patients). Primary endpoint is the in-hospital incidence of AFF after cardiac surgery. Secondary endpoints are: in-hospital AFF in medical patients or patients after non-cardiac surgery, actually achieved potassium levels and their variation, electrolyte and glucose levels, potassium and insulin requirements, cumulative fluid balance, (ICU) length of stay, ICU mortality, hospital mortality and 90-day mortality.DiscussionThe GRIP-COMPASS trial is the first controlled clinical trial to date that compares potassium targets. Other novel methodological elements of the study are that it is performed in ICU patients where both targets are within the normal range and that a computer-assisted potassium suppletion algorithm is used.Trial registrationNCT 01085071 at ClinicalTrials.gov

【 授权许可】

CC BY   
© Hoekstra et al; licensee BioMed Central Ltd. 2010