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Comparison of Two Potassium Targets Within the Normal Range in Intensive Care Patients (GRIP-COMPASS)

Primary Purpose

Thoracic Surgery, Cardiac Surgery, Critically Ill

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Potassium Chloride
Potassium Chloride
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Surgery focused on measuring 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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University Medical Center Groningen, University of Groningen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Normal-high potassium (NHP)

Normal-low potassium (NLP)

Arm Description

A potassium target of 4.5 mmol/L.

A potassium target of 4.0 mmol/L.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Potassium regulation within 3.5 to 5.0 mmol/L.
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
AFib or AFl in other patients, i.e. patients who did not undergo CABG 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.
Biochemical disturbances including electrolytes (Na, K, Mg, Ca), blood gas analysis, lactate, renal function (creatinine, urea).
Cumulative fluid balance.
Mortality and (ICU) length of stay.
Glucose regulation
The relation with glucose levels and insulin administration

Full Information

First Posted
March 1, 2010
Last Updated
January 18, 2013
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT01085071
Brief Title
Comparison of Two Potassium Targets Within the Normal Range in Intensive Care Patients
Acronym
GRIP-COMPASS
Official Title
GRIP-COMPASS Trial: Computer-driven Glucose and Potassium Regulation Program in Intensive Care Patients With COMparison of PotASSium Targets Within normokAlemic Range
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal-high potassium (NHP)
Arm Type
Active Comparator
Arm Description
A potassium target of 4.5 mmol/L.
Arm Title
Normal-low potassium (NLP)
Arm Type
Active Comparator
Arm Description
A potassium target of 4.0 mmol/L.
Intervention Type
Drug
Intervention Name(s)
Potassium Chloride
Intervention Description
KCl is continuously administered and titrated towards a Normal-high Potassium (4.5 mmol/L)
Intervention Type
Drug
Intervention Name(s)
Potassium Chloride
Intervention Description
KCl is continuously administered and titrated towards a Normal-low Potassium (4.0 mmol/L)
Primary Outcome Measure Information:
Title
AFib or AFl in patients who underwent CABG (coronary artery bypass grafting) or valvular surgery.
Description
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
First 7d after Intensive Care Unit admission or hospital discharge, whichever is earlier.
Secondary Outcome Measure Information:
Title
Potassium regulation within 3.5 to 5.0 mmol/L.
Description
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Time Frame
From Intensive Care Unit admission to hospital discharge.
Title
AFib or AFl in other patients, i.e. patients who did not undergo CABG or valvular surgery.
Description
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
First 7d after ICU-admission or hospital discharge, whichever is earlier.
Title
Biochemical disturbances including electrolytes (Na, K, Mg, Ca), blood gas analysis, lactate, renal function (creatinine, urea).
Time Frame
From ICU-admission to hospital discharge.
Title
Cumulative fluid balance.
Time Frame
During ICU-stay.
Title
Mortality and (ICU) length of stay.
Time Frame
ICU-mortality and hospital-mortality as well as 90-day mortality.
Title
Glucose regulation
Description
The relation with glucose levels and insulin administration
Time Frame
During ICU-admission.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix Zijlstra, MD/PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maarten WN Nijsten, MD/PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen, University of Groningen
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
16359559
Citation
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.
Results Reference
background
PubMed Identifier
18389221
Citation
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.
Results Reference
background
PubMed Identifier
19849827
Citation
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.
Results Reference
background
PubMed Identifier
20100342
Citation
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.
Results Reference
background
PubMed Identifier
26856215
Citation
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.
Results Reference
derived
PubMed Identifier
21194419
Citation
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.
Results Reference
derived

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

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