University Medical Center Groningen, University of Groningen
Groningen, Provincie Groningen, 9700RB, Netherlands
NCT Number: NCT01085071
Rationale: It is well known that distinctly abnormal blood potassium values can cause serious complications such as cardiac arrhythmias. Although potassium regulation is generally considered important, hardly any research has been done about potassium regulation in intensive care patients. The investigators hypothesize that different potassium target-values, within the as normal accepted range, may have different effects in critically ill patients.
Study design: A prospective trial comparing two different potassium target-values. Potassium will be tightly regulated with the already fully operational GRIP-II computer program.
Study population: 1200 adult patients admitted at the thoracic intensive care unit of the University Medical Center Groningen.
Intervention: Comparison between two variations of standard therapy: potassium target-value of 4.0 mmol/L versus 4.5 mmol/L.
Main study parameters/endpoints: The primary endpoint is the incidence of atrial fibrillation or atrial flutter from ICU-admission to hospital discharge. Secondary endpoints are serum levels of potassium and the other main electrolytes, renal function and renal potassium excretion, the relation with insulin and glucose, the cumulative fluid balance, (ICU) length of stay and mortality.
Looking for future studies?
Notify Me16 year and older
All sexes
Interventional
Phase 4
Groningen, Provincie Groningen, 9700RB, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
KCl is continuously administered and titrated towards a Normal-high Potassium (4.5 mmol/L)
Time frame: First 7d after Intensive Care Unit admission or hospital discharge, whichever is earlier.
Post-surgery AFib and AFl typically occur within days after surgery. AFib and AFl can only be reliably assessed during ICU stay and hospital stay. Therefore this outcome measure is not determined after hospital discharge.
Time frame: From Intensive Care Unit admission to hospital discharge.
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Time frame: First 7d after ICU-admission or hospital discharge, whichever is earlier.
Post-surgery AFib and AFl typically occur within days after surgery. AFib and AFl can only be reliably assessed during ICU stay and hospital stay. Therefore this outcome measure is not determined after hospital discharge.
Time frame: From ICU-admission to hospital discharge.
Time frame: During ICU-stay.
Time frame: ICU-mortality and hospital-mortality as well as 90-day mortality.
Time frame: During ICU-admission.
The relation with glucose levels and insulin administration
University Medical Center Groningen
Other
GRIP-COMPASS Trial: Computer-driven Glucose and Potassium Regulation Program in Intensive Care Patients With COMparison of PotASSium Targets Within normokAlemic Range
Acronym: GRIP-COMPASS
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.
Published trials that share one or more normalized conditions with this study.
NCT06605066
Algorithms, Behavior
Bolu, Turkey (Türkiye)
View Trial DetailsNCT01985425
Arrhythmias, Cardiac, Atrial Fibrillation
Winnipeg, Manitoba, Canada
View Trial DetailsNCT02976415
Cardiac Disease, Cardiovascular Diseases
Hamilton, Ontario, Canada
View Trial DetailsNCT02964026
Cardiac Surgery, Heart Surgery
View Trial Details