HyperglycemiaPhase 3CHyCSNCT02574156
Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial
A Phase 3 study testing Insulin in people with Hyperglycemia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The investigators aim to study the impact of a strategy of a intensive glycemic control in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2017to 1 Apr 2019
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing heart surgery;
- Age greater than 18 years;
- Sign the informed consent form;
- Capillary blood glucose greater than 200mg/dL ICU admission
Who cannot join
- Admitted for surgical repair of congenital heart defects;
- Dialytic Chronic renal failure;
- Participation in other research protocol;
- Diagnosis of HIV/AIDS;
- Pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to study the impact of a strategy of a intensive glycemic control in patients undergoing cardiac surgery.
Read the detailed description
Patients undergoing heart surgery at the Heart Institute (InCor) will be randomized and in accordance with a list of random numbers, generated by a computer program, are allocated in one of the treatment groups (conventional or intensive) when the blood glucose value recorded is greater than 200 mg/dl on two consecutive measures in an interval of 30 minutes.Conventional Group (GCon): patients randomized to the conventional group will receive insulin infusion in a dilution of 100 units of regular insulin in 100 ml of physiological solution (NaCl 0.9%) in continuous infusion pump for maintenance of blood glucose between 140 mg/dl and 180 mg/dl.
Group intensive (GInt): patients randomized to the intensive group will receive insulin infusion in a dilution of 100 units of regular insulin in 100 ml of physiological solution (NaCl 0.9%) in continuous infusion pump for maintenance of blood glucose between 90 mg/dl and 110 mg/dl.
The insulin dose adjustment will be based on measurements of arterial blood glucose undiluted, held at intervals of one to 4 hours with the use of a monitoring system of glucose and beta-blood ketone (Freestyle Precision Pro, Abbott). The dosage is adjusted according to an algorithm by a team of intensive care nurses, trained for this purpose and assisted by a study physician not involved in the clinical care of patients.
On admission, all patients will receive intravenous glucose solution continuously (200 to 300 g in 24 hours). As soon as possible, the patient will be nurtured according to the routine of Surgical ICU for nutrition in the postoperative period of cardiac surgery patient.
- Conditions
- Hyperglycemia
- Being tested
- Insulin
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Also called Glycemic Control
All patients will receive insulin. However, the infusion flow will be different according to the group.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Group | Experimental | Patients randomized for Conventional Group will receive insulin infusion of regular insulin (100 UI) in 100 mL of saline in continuous infusion pump for maintenance of blood glucose between 140 mg/dl and 180 mg/dl. Receives: Drug: Insulin |
| Moderate Group | Experimental | Patients randomized for ModerateGroup will receive insulin infusion of regular insulin (100 UI) in 100 mL of saline in continuous infusion pump for maintenance of blood glucose between 100 mg/dl and 130 mg/dl. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection of surgical wound infection
The primary outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines
Measured: 30 days
Secondary outcomes (6)
Need for reoperation
This outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines
Measured: 30 days
Acute renal injury (defined by the KDIGO classification)
This outcome measure will be assessed according to the KDIGO Criterion
Measured: 30 days
Infection of the bloodstream
Measured: 90 days
Prolonged mechanical ventilation
Measured: 90 days
Need for transfusion of blood products
Measured: 90 days
Occurrences of hypoglycemia
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study start1 Jan 2017
- Primary completion1 Aug 2018
- Study completion1 Apr 2019
Why it stopped: Finished
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute
- Responsible party
- Principal investigator, Eduesley Santana Santos, University of Sao Paulo
- Investigators
- Eduesley Santana Santos, Ph.D, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574156
- Sponsor's protocol ID
- SDC
- Acronym
- CHyCS
- Status last verified
- Oct 2022
- First submitted
- 8 Oct 2015
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Macrae D, Grieve R, Allen E, Sadique Z, Morris K, Pappachan J, Parslow R, Tasker RC, Elbourne D; CHiP Investigators. A randomized trial of hyperglycemic control in pediatric intensive care. N Engl J Med. 2014 Jan 9;370(2):107-18. doi: 10.1056/NEJMoa1302564.
PubMed 24401049Yates AR, Dyke PC 2nd, Taeed R, Hoffman TM, Hayes J, Feltes TF, Cua CL. Hyperglycemia is a marker for poor outcome in the postoperative pediatric cardiac patient. Pediatr Crit Care Med. 2006 Jul;7(4):351-5. doi: 10.1097/01.PCC.0000227755.96700.98.
PubMed 16738506NICE-SUGAR Study Investigators; Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hebert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco JJ. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009 Mar 26;360(13):1283-97. doi: 10.1056/NEJMoa0810625. Epub 2009 Mar 24.
PubMed 19318384Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, Olthoff D, Jaschinski U, John S, Rossaint R, Welte T, Schaefer M, Kern P, Kuhnt E, Kiehntopf M, Hartog C, Natanson C, Loeffler M, Reinhart K; German Competence Network Sepsis (SepNet). Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med. 2008 Jan 10;358(2):125-39. doi: 10.1056/NEJMoa070716.
PubMed 18184958Preiser JC, Devos P, Ruiz-Santana S, Melot C, Annane D, Groeneveld J, Iapichino G, Leverve X, Nitenberg G, Singer P, Wernerman J, Joannidis M, Stecher A, Chiolero R. A prospective randomised multi-centre controlled trial on tight glucose control by intensive insulin therapy in adult intensive care units: the Glucontrol study. Intensive Care Med. 2009 Oct;35(10):1738-48. doi: 10.1007/s00134-009-1585-2. Epub 2009 Jul 28.
PubMed 19636533Dandona P, Mohanty P, Chaudhuri A, Garg R, Aljada A. Insulin infusion in acute illness. J Clin Invest. 2005 Aug;115(8):2069-72. doi: 10.1172/JCI26045.
PubMed 16075050Boyle EM Jr, Pohlman TH, Johnson MC, Verrier ED. Endothelial cell injury in cardiovascular surgery: the systemic inflammatory response. Ann Thorac Surg. 1997 Jan;63(1):277-84. doi: 10.1016/s0003-4975(96)01061-2.
PubMed 8993292Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 3--valve plus coronary artery bypass grafting surgery. Ann Thorac Surg. 2009 Jul;88(1 Suppl):S43-62. doi: 10.1016/j.athoracsur.2009.05.055.
PubMed 19559824
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial
- ClinicalTrials.gov ID
- NCT02574156
- Acronym / sponsor ID
- CHyCS / SDC
- Conditions
- Hyperglycemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Finished
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- InCor Heart Institute
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 12 Oct 2015 (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.
The investigators aim to study the impact of a strategy of a intensive glycemic control in patients undergoing cardiac surgery.
Detailed description
Patients undergoing heart surgery at the Heart Institute (InCor) will be randomized and in accordance with a list of random numbers, generated by a computer program, are allocated in one of the treatment groups (conventional or intensive) when the blood glucose value recorded is greater than 200 mg/dl on two consecutive measures in an interval of 30 minutes.Conventional Group (GCon): patients randomized to the conventional group will receive insulin infusion in a dilution of 100 units of regular insulin in 100 ml of physiological solution (NaCl 0.9%) in continuous infusion pump for maintenance of blood glucose between 140 mg/dl and 180 mg/dl.
Group intensive (GInt): patients randomized to the intensive group will receive insulin infusion in a dilution of 100 units of regular insulin in 100 ml of physiological solution (NaCl 0.9%) in continuous infusion pump for maintenance of blood glucose between 90 mg/dl and 110 mg/dl.
The insulin dose adjustment will be based on measurements of arterial blood glucose undiluted, held at intervals of one to 4 hours with the use of a monitoring system of glucose and beta-blood ketone (Freestyle Precision Pro, Abbott). The dosage is adjusted according to an algorithm by a team of intensive care nurses, trained for this purpose and assisted by a study physician not involved in the clinical care of patients.
On admission, all patients will receive intravenous glucose solution continuously (200 to 300 g in 24 hours). As soon as possible, the patient will be nurtured according to the routine of Surgical ICU for nutrition in the postoperative period of cardiac surgery patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Group | Experimental | Drug: InsulinPatients randomized for Conventional Group will receive insulin infusion of regular insulin (100 UI) in 100 mL of saline in continuous infusion pump for maintenance of blood glucose between 140 mg/dl and 180 mg/dl. |
| Moderate Group | Experimental | Drug: InsulinPatients randomized for ModerateGroup will receive insulin infusion of regular insulin (100 UI) in 100 mL of saline in continuous infusion pump for maintenance of blood glucose between 100 mg/dl and 130 mg/dl. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing heart surgery;
- Age greater than 18 years;
- Sign the informed consent form;
- Capillary blood glucose greater than 200mg/dL ICU admission
Key exclusion criteria (5 listed)
- Admitted for surgical repair of congenital heart defects;
- Dialytic Chronic renal failure;
- Participation in other research protocol;
- Diagnosis of HIV/AIDS;
- Pregnant.
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 |
|---|---|---|
| InsulinAlso: Glycemic ControlAll patients will receive insulin. However, the infusion flow will be different according to the group. | Drug | Conventional Group, Moderate Group |
Primary outcome
Infection of surgical wound infection
Time frame: 30 days
The primary outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines
6 secondary outcomes
Need for reoperation
Time frame: 30 days
Acute renal injury (defined by the KDIGO classification)
Time frame: 30 days
Infection of the bloodstream
Time frame: 90 days
Prolonged mechanical ventilation
Time frame: 90 days
Need for transfusion of blood products
Time frame: 90 days
Occurrences of hypoglycemia
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Finished). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Results publication: PubMed 24401049Macrae D, Grieve R, Allen E, Sadique Z, Morris K, Pappachan J, Parslow R, Tasker RC, Elbourne D; CHiP Investigators. A randomized trial of hyperglycemic control in pediatric intensive care. N Engl J Med. 2014 Jan 9;370(2):107-18. doi: 10.1056/NEJMoa1302564.
- Results publication: PubMed 16738506Yates AR, Dyke PC 2nd, Taeed R, Hoffman TM, Hayes J, Feltes TF, Cua CL. Hyperglycemia is a marker for poor outcome in the postoperative pediatric cardiac patient. Pediatr Crit Care Med. 2006 Jul;7(4):351-5. doi: 10.1097/01.PCC.0000227755.96700.98.
- Results publication: PubMed 19318384NICE-SUGAR Study Investigators; Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hebert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco JJ. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009 Mar 26;360(13):1283-97. doi: 10.1056/NEJMoa0810625. Epub 2009 Mar 24.
- Results publication: PubMed 18184958Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, Olthoff D, Jaschinski U, John S, Rossaint R, Welte T, Schaefer M, Kern P, Kuhnt E, Kiehntopf M, Hartog C, Natanson C, Loeffler M, Reinhart K; German Competence Network Sepsis (SepNet). Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med. 2008 Jan 10;358(2):125-39. doi: 10.1056/NEJMoa070716.
- Results publication: PubMed 19636533Preiser JC, Devos P, Ruiz-Santana S, Melot C, Annane D, Groeneveld J, Iapichino G, Leverve X, Nitenberg G, Singer P, Wernerman J, Joannidis M, Stecher A, Chiolero R. A prospective randomised multi-centre controlled trial on tight glucose control by intensive insulin therapy in adult intensive care units: the Glucontrol study. Intensive Care Med. 2009 Oct;35(10):1738-48. doi: 10.1007/s00134-009-1585-2. Epub 2009 Jul 28.
- Results publication: PubMed 16075050Dandona P, Mohanty P, Chaudhuri A, Garg R, Aljada A. Insulin infusion in acute illness. J Clin Invest. 2005 Aug;115(8):2069-72. doi: 10.1172/JCI26045.
- Results publication: PubMed 8993292Boyle EM Jr, Pohlman TH, Johnson MC, Verrier ED. Endothelial cell injury in cardiovascular surgery: the systemic inflammatory response. Ann Thorac Surg. 1997 Jan;63(1):277-84. doi: 10.1016/s0003-4975(96)01061-2.
- Results publication: PubMed 19559824Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 3--valve plus coronary artery bypass grafting surgery. Ann Thorac Surg. 2009 Jul;88(1 Suppl):S43-62. doi: 10.1016/j.athoracsur.2009.05.055.
- Individual participant dataSharing planned: Yes
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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.
Eduesley Santana Santos, Ph.D principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin in people with Hyperglycemia, run by University of Sao Paulo at 1 site in Brazil.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 4 Nov 2022. 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Finished). Results are not available in the source record.
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?
Infection of surgical wound infection (time frame: 30 days). 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 NCT02574156, which also lists 8 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 4 Nov 2022.