Comparison of Two Potassium Targets Within the Normal Range in Intensive Care Patients

NCT01085071 | Completed Phase 4

• 1 other identifier: GRIP-COMPASS trial
• Study Type: interventional
• Target: 1,225
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgery; Cardiac Surgery; Critically Ill

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

Outcome Measures

Primary Outcomes (1)

• AFib or AFl in patients who underwent CABG (coronary artery bypass grafting) or valvular surgery.

  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.

  First 7d after Intensive Care Unit admission or hospital discharge, whichever is earlier.

Secondary Outcomes (6)

• Potassium regulation within 3.5 to 5.0 mmol/L.

  From Intensive Care Unit admission to hospital discharge.

• 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.

• Biochemical disturbances including electrolytes (Na, K, Mg, Ca), blood gas analysis, lactate, renal function (creatinine, urea).

  From ICU-admission to hospital discharge.

• Cumulative fluid balance.

  During ICU-stay.

• Mortality and (ICU) length of stay.

  ICU-mortality and hospital-mortality as well as 90-day mortality.

Study Arms (2)

Normal-high potassium (NHP)

ACTIVE COMPARATOR

A potassium target of 4.5 mmol/L.

Drug: Potassium Chloride

Normal-low potassium (NLP)

ACTIVE COMPARATOR

A potassium target of 4.0 mmol/L.

Drug: Potassium Chloride

Interventions

Potassium Chloride DRUG

KCl is continuously administered and titrated towards a Normal-high Potassium (4.5 mmol/L)

Normal-high potassium (NHP)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients admitted to the thoracic and surgical ICU of the University Medical Center Groningen.
• Computerized potassium regulation with GRIP-II

You may not qualify if:

• Patients who are not potassium regulated with GRIP-II (patients who take their own meals).

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen, University of Groningen

Groningen, Provincie Groningen, 9700RB, Netherlands

Location

Related Publications (6)

• Vogelzang M, Zijlstra F, Nijsten MW. Design and implementation of GRIP: a computerized glucose control system at a surgical intensive care unit. BMC Med Inform Decis Mak. 2005 Dec 19;5:38. doi: 10.1186/1472-6947-5-38.

  PMID: 16359559 BACKGROUND

• Vogelzang M, Loef BG, Regtien JG, van der Horst IC, van Assen H, Zijlstra F, Nijsten MW. Computer-assisted glucose control in critically ill patients. Intensive Care Med. 2008 Aug;34(8):1421-7. doi: 10.1007/s00134-008-1091-y. Epub 2008 Apr 4.

  PMID: 18389221 BACKGROUND

• Hoekstra M, Vogelzang M, Verbitskiy E, Nijsten MW. Health technology assessment review: Computerized glucose regulation in the intensive care unit--how to create artificial control. Crit Care. 2009;13(5):223. doi: 10.1186/cc8023. Epub 2009 Oct 16.

  PMID: 19849827 BACKGROUND

• Hoekstra M, Vogelzang M, Drost JT, Janse M, Loef BG, van der Horst IC, Zijlstra F, Nijsten MW. Implementation and evaluation of a nurse-centered computerized potassium regulation protocol in the intensive care unit--a before and after analysis. BMC Med Inform Decis Mak. 2010 Jan 25;10:5. doi: 10.1186/1472-6947-10-5.

  PMID: 20100342 BACKGROUND

• Hoekstra M, Hessels L, Rienstra M, Yeh L, Lansink AO, Vogelzang M, van der Horst IC, van der Maaten JM, Mariani MA, de Smet AM, Struys MM, Zijlstra F, Nijsten MW. Computer-guided normal-low versus normal-high potassium control after cardiac surgery: No impact on atrial fibrillation or atrial flutter. Am Heart J. 2016 Feb;172:45-52. doi: 10.1016/j.ahj.2015.10.020. Epub 2015 Nov 11.

  PMID: 26856215 DERIVED

• Hoekstra M, Vogelzang M, van der Horst IC, Lansink AO, van der Maaten JM, Ismael F, Zijlstra F, Nijsten MW. Trial design: Computer guided normal-low versus normal-high potassium control in critically ill patients: Rationale of the GRIP-COMPASS study. BMC Anesthesiol. 2010 Dec 31;10:23. doi: 10.1186/1471-2253-10-23.

  PMID: 21194419 DERIVED

MeSH Terms

Conditions

Critical Illness; Atrial Fibrillation

Interventions

Potassium Chloride

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Potassium Compounds

Study Officials

• Felix Zijlstra, MD/PhD

  University Medical Center Groningen

  STUDY DIRECTOR

• Maarten WN Nijsten, MD/PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 11, 2010
• Study Start: June 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 21, 2013

Record last verified: 2013-01

Locations

NL (1)