Hyperglycaemia During Perioperative PeriodPhase 1NCT00370643
Glucose Control in Open Heart Surgery
A Phase 1 study testing human regular insulin in people with Hyperglycaemia During Perioperative Period and Heart Valve Diseases, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of the study is to seek if there is difference to state glucose level in 80-120mg/dl or 200mg/dl in patients submitted to open heart surgery Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hyperglycaemia During Perioperative Period, Heart Valve Diseases, Ventricular Dysfunction
- What is being tested?
- human regular insulin
- How many people
- 98 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2002to Nov 2004
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult more than 21 years old
- open heart surgery with cardiopulmonary bypass
Who cannot join
- renal dysfunction
- reoperation
- use of inotropic support
- neurological dysfunction
- chronic pulmonary obstructive disease
- emergency or urgency
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute, Hospital of Clinics, São Paulo University Medical School
São Paulo, São Paulo, 05403-000
About this study
Official title: Intensive Glucose Control Versus Conventional:Tendency Of Better Clinical Outcome In Open Heart Surgery
The purpose of the study is to seek if there is difference to state glucose level in 80-120mg/dl or 200mg/dl in patients submitted to open heart surgery
Read the detailed description
Hyperglycaemia in the intensive care unit and perioperative period has been accused to be one of the causes of worse clinical outcome. It is known that in open heart surgeries the glucose level must be set less than 200mg/dl, but new trials had set the glucose level lower than that: 140mg/dl in some studies and even lower (80-110mg/dl). Our trial had the intention to seek if there is difference setting glucose level in 2 different ones would modifies clinical outcome.
- Being tested
- human regular insulin
- Keywords
- hyperglycaemia, open heart surgery, intensive care unit
- Medical subject headings
- Heart Valve Diseases, Ventricular Dysfunction, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human regular insulinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of intubation
ICU length
Blood transfusion
Infection rate
Renal dysfunction
Neurological dysfunction
Hospital length
Mortality
Secondary outcomes (6)
Length of surgery
Length of cardiopulmonary bypass
Physical status
EuroSCORE
Parsonnet
Canadian Multicenter index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startOct 2002
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hyperglycaemia During Perioperative PeriodStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Jose O Costa Auler Junior, Professor, Principal investigator, Heart instutute, Hospital of Clinics, São Paulo University Medical SchoolRaquel PC Chan, Study chair, Heart Institute, Hospital of Clinics, São Paulo University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370643
- Sponsor's protocol ID
- number: 637-02
- Status last verified
- Feb 2009
- First submitted
- 30 Aug 2006
- Last updated
- 19 Feb 2009
- Results posted
- No
Publications
van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
PubMed 11794168Zerr KJ, Furnary AP, Grunkemeier GL, Bookin S, Kanhere V, Starr A. Glucose control lowers the risk of wound infection in diabetics after open heart operations. Ann Thorac Surg. 1997 Feb;63(2):356-61. doi: 10.1016/s0003-4975(96)01044-2.
PubMed 9033300Chan RP, Galas FR, Hajjar LA, Bello CN, Piccioni MA, Auler JO Jr. Intensive perioperative glucose control does not improve outcomes of patients submitted to open-heart surgery: a randomized controlled trial. Clinics (Sao Paulo). 2009;64(1):51-60. doi: 10.1590/s1807-59322009000100010.
PubMed 19142552
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Glucose Control Versus Conventional:Tendency Of Better Clinical Outcome In Open Heart Surgery
- ClinicalTrials.gov ID
- NCT00370643
- Acronym / sponsor ID
- number: 637-02
- Keywords
- hyperglycaemia, open heart surgery, intensive care unit
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Oct 2002
- Study completion
- Nov 2004
- First posted
- 1 Sep 2006 (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 purpose of the study is to seek if there is difference to state glucose level in 80-120mg/dl or 200mg/dl in patients submitted to open heart surgery
Detailed description
Hyperglycaemia in the intensive care unit and perioperative period has been accused to be one of the causes of worse clinical outcome. It is known that in open heart surgeries the glucose level must be set less than 200mg/dl, but new trials had set the glucose level lower than that: 140mg/dl in some studies and even lower (80-110mg/dl). Our trial had the intention to seek if there is difference setting glucose level in 2 different ones would modifies clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult more than 21 years old
- open heart surgery with cardiopulmonary bypass
Key exclusion criteria (6 listed)
- renal dysfunction
- reoperation
- use of inotropic support
- neurological dysfunction
- chronic pulmonary obstructive disease
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 |
|---|---|---|
| human regular insulin | Drug | – |
Primary outcome
Duration of intubation
ICU length
Blood transfusion
Infection rate
Renal dysfunction
Neurological dysfunction
Hospital length
Mortality
6 secondary outcomes
Length of surgery
Length of cardiopulmonary bypass
Physical status
EuroSCORE
Parsonnet
Canadian Multicenter index
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 19 Feb 2009.
- Results publication: PubMed 11794168van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
- Results publication: PubMed 9033300Zerr KJ, Furnary AP, Grunkemeier GL, Bookin S, Kanhere V, Starr A. Glucose control lowers the risk of wound infection in diabetics after open heart operations. Ann Thorac Surg. 1997 Feb;63(2):356-61. doi: 10.1016/s0003-4975(96)01044-2.
- Derived from this study: PubMed 19142552Chan RP, Galas FR, Hajjar LA, Bello CN, Piccioni MA, Auler JO Jr. Intensive perioperative glucose control does not improve outcomes of patients submitted to open-heart surgery: a randomized controlled trial. Clinics (Sao Paulo). 2009;64(1):51-60. doi: 10.1590/s1807-59322009000100010.
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.
Jose O Costa Auler Junior, Professor principal investigator
Heart instutute, Hospital of Clinics, São Paulo University Medical School
Raquel PC Chan study chair
Heart Institute, Hospital of Clinics, São Paulo University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing human regular insulin in people with Hyperglycaemia During Perioperative Period and Heart Valve Diseases, 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 2 inclusion and 6 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 19 Feb 2009. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Duration of intubation. The study lists 8 primary outcomes in all. 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 NCT00370643, which also lists 3 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 19 Feb 2009.