Thoracic SurgeryPhase 4GRIP-COMPASSNCT01085071
Comparison of Two Potassium Targets Within the Normal Range in Intensive Care Patients
A Phase 4 study testing Potassium Chloride in people with Thoracic Surgery and Cardiac Surgery, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Thoracic Surgery, Cardiac Surgery, Critically Ill
- What is being tested?
- Potassium Chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,225 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2009to Jan 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All adult patients admitted to the thoracic and surgical ICU of the University Medical Center Groningen.
- Computerized potassium regulation with GRIP-II
Who cannot join
- Patients who are not potassium regulated with GRIP-II (patients who take their own meals).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen, University of Groningen
Groningen, Provincie Groningen, 9700RB
About this study
Official title: GRIP-COMPASS Trial: Computer-driven Glucose and Potassium Regulation Program in Intensive Care Patients With COMparison of PotASSium Targets Within normokAlemic Range
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.
Read more
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
- Being tested
- Potassium Chloride
- 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
- Medical subject headings
- Critical Illness, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium ChlorideDrug
KCl is continuously administered and titrated towards a Normal-high Potassium (4.5 mmol/L)
Potassium ChlorideDrug
KCl is continuously administered and titrated towards a Normal-low Potassium (4.0 mmol/L)
| Study group | Role | What they receive |
|---|---|---|
| Normal-high potassium (NHP) | Active comparator | A potassium target of 4.5 mmol/L. Receives: Drug: Potassium Chloride |
| Normal-low potassium (NLP) | Active comparator | A potassium target of 4.0 mmol/L. Receives: Drug: Potassium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Measured: 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.
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.
Measured: 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).
Measured: From ICU-admission to hospital discharge.
Cumulative fluid balance.
Measured: During ICU-stay.
Mortality and (ICU) length of stay.
Measured: ICU-mortality and hospital-mortality as well as 90-day mortality.
Glucose regulation
The relation with glucose levels and insulin administration
Measured: During ICU-admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Hoekstra, University Medical Center Groningen
- Investigators
- Felix Zijlstra, MD/PhD, Study director, University Medical Center GroningenMaarten WN Nijsten, MD/PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085071
- Sponsor's protocol ID
- GRIP-COMPASS trial
- Acronym
- GRIP-COMPASS
- Status last verified
- Jan 2013
- First submitted
- 1 Mar 2010
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16359559Vogelzang 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.
PubMed 18389221Hoekstra 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.
PubMed 19849827Hoekstra 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.
PubMed 20100342Hoekstra 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.
PubMed 26856215Hoekstra 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.
PubMed 21194419
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GRIP-COMPASS Trial: Computer-driven Glucose and Potassium Regulation Program in Intensive Care Patients With COMparison of PotASSium Targets Within normokAlemic Range
- ClinicalTrials.gov ID
- NCT01085071
- Acronym / sponsor ID
- GRIP-COMPASS / GRIP-COMPASS trial
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,225 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal-high potassium (NHP) | Active comparator | Drug: Potassium ChlorideA potassium target of 4.5 mmol/L. |
| Normal-low potassium (NLP) | Active comparator | Drug: Potassium ChlorideA potassium target of 4.0 mmol/L. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients admitted to the thoracic and surgical ICU of the University Medical Center Groningen.
- Computerized potassium regulation with GRIP-II
Key exclusion criteria (1 listed)
- Patients who are not potassium regulated with GRIP-II (patients who take their own meals).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potassium ChlorideKCl is continuously administered and titrated towards a Normal-high Potassium (4.5 mmol/L) | Drug | Normal-high potassium (NHP) |
| Potassium ChlorideKCl is continuously administered and titrated towards a Normal-low Potassium (4.0 mmol/L) | Drug | Normal-low potassium (NLP) |
Primary outcome
AFib or AFl in patients who underwent CABG (coronary artery bypass grafting) or valvular surgery.
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.
6 secondary outcomes
Potassium regulation within 3.5 to 5.0 mmol/L.
Time frame: 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.
Time frame: 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).
Time frame: From ICU-admission to hospital discharge.
Cumulative fluid balance.
Time frame: During ICU-stay.
Mortality and (ICU) length of stay.
Time frame: ICU-mortality and hospital-mortality as well as 90-day mortality.
Glucose regulation
Time frame: During ICU-admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2013.
- Background: PubMed 16359559Vogelzang 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.
- Background: PubMed 18389221Vogelzang 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.
- Background: PubMed 19849827Hoekstra 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.
- Background: PubMed 20100342Hoekstra 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.
- Derived from this study: PubMed 26856215Hoekstra 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.
- Derived from this study: PubMed 21194419Hoekstra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Zijlstra, MD/PhD study director
University Medical Center Groningen
Maarten WN Nijsten, MD/PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Potassium Chloride in people with Thoracic Surgery and Cardiac Surgery, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AFib or AFl in patients who underwent CABG (coronary artery bypass grafting) or valvular surgery. (time frame: First 7d after Intensive Care Unit admission or hospital discharge, whichever is earlier.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01085071, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2013.