Cardiac Surgery, Critically Ill, Thoracic Surgery
Conditions
Keywords
intensive care unit, potassium, atrial fibrillation, cardiac surgery, Critically ill patients post CABG and/or valvular surgery, Critically ill patients not post CABG and/or valvular surgery, coronary artery bypass graft
Brief summary
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.
Interventions
DRUGPotassium Chloride
KCl is continuously administered and titrated towards a Normal-high Potassium (4.5 mmol/L)
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult patients admitted to the thoracic and surgical ICU of the University Medical Center Groningen. * Computerized potassium regulation with GRIP-II
Exclusion criteria
* Patients who are not potassium regulated with GRIP-II (patients who take their own meals).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AFib or AFl in patients who underwent CABG (coronary artery bypass grafting) or valvular surgery. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AFib or AFl in other patients, i.e. patients who did not undergo CABG or valvular surgery. | 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. |
| Biochemical disturbances including electrolytes (Na, K, Mg, Ca), blood gas analysis, lactate, renal function (creatinine, urea). | From ICU-admission to hospital discharge. | — |
| Potassium regulation within 3.5 to 5.0 mmol/L. | From Intensive Care Unit admission to hospital discharge. | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. |
| Mortality and (ICU) length of stay. | ICU-mortality and hospital-mortality as well as 90-day mortality. | — |
| Glucose regulation | During ICU-admission. | The relation with glucose levels and insulin administration |
| Cumulative fluid balance. | During ICU-stay. | — |
Countries
Netherlands
Outcome results
None listed