Nosocomial InfectionTGCNCT01225159
Tight Glycaemic Control During Cardiac Surgery
A study testing TGC in people with Nosocomial Infection and External Causes of Morbidity and Mortality, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
To determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Nosocomial Infection, External Causes of Morbidity and Mortality, Hypoglycemia
- What is being tested?
- TGC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age > 15 years
- cardiac surgery with cardiopulmonary bypass
Who cannot join
- active infection
- insulin allergy
- off-pump cardiopulmonary bypass procedures
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Songklanagarind Hospital, Faculty of Medicine, PSU
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Safety and Efficacy of Tight Glycaemic Control During Cardiac Surgery
To determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality
Read the detailed description
Hyperglycaemia develops frequently in patients undergoing cardiac surgery, especially following cardiopulmonary bypass (CPB). Recent evidence suggests that acute hyperglycaemia adversely affects immune function, wound healing and cardiovascular function.
- Being tested
- TGC, Conventional glycaemic control
- Keywords
- tight glycemic control, cardiac surgery
- Medical subject headings
- Cross Infection, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGCDrug
Also called intensive glycaemic control
TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL.
Conventional glycaemic controlDrug
Also called Control group
Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.
| Study group | Role | What they receive |
|---|---|---|
| Tight glycaemic control (TGC) | Experimental | TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL. Receives: Drug: TGC |
| Conventional glycaemic control (Control) | Placebo comparator | Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%. Receives: Drug: Conventional glycaemic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nosocomial Infection
Infection rate referred to the rate of nosocomial infection, including pneumonia, central line infection, surgical wound infection, deep sternal wound infection, urinary tract infection, and sepsis. Infections were defined according to the Centers for Disease Control and Prevention (CDC) definitions, occurring within 30 days postoperative cardiac surgery.
Measured: within the first 30 day after surgery
Secondary outcomes (1)
Morbidities and All Causes Mortality
morbidities defined as hypoglycaemia (blood sugar less than 60 mg/dL), Stroke (focal neurological deficit confirmed with CT or MRI), acute renal failure (rising of creatinine)
Measured: within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startSep 2008
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Hypoglycaemia is significantly higher in TGC
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nosocomial InfectionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panthila Rujirojindakul, Prince of Songkla University
- Investigators
- Panthila Rujirojindakul, M.D., Principal investigator, Faculty of Medicine, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225159
- Sponsor's protocol ID
- SUB.EC 51-1008-08-1-1
- Acronym
- TGC
- Status last verified
- Nov 2015
- First submitted
- 29 Jul 2010
- Last updated
- 18 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Tight Glycaemic Control During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01225159
- Acronym / sponsor ID
- TGC / SUB.EC 51-1008-08-1-1
- Keywords
- tight glycemic control, cardiac surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Hypoglycaemia is significantly higher in TGC
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Posted 18 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality
Detailed description
Hyperglycaemia develops frequently in patients undergoing cardiac surgery, especially following cardiopulmonary bypass (CPB). Recent evidence suggests that acute hyperglycaemia adversely affects immune function, wound healing and cardiovascular function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tight glycaemic control (TGC) | Experimental | Drug: TGCTGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL. |
| Conventional glycaemic control (Control) | Placebo comparator | Drug: Conventional glycaemic controlConventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- age > 15 years
- cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (3 listed)
- active infection
- insulin allergy
- off-pump cardiopulmonary bypass procedures
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 |
|---|---|---|
| TGCAlso: intensive glycaemic controlTGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL. | Drug | Tight glycaemic control (TGC) |
| Conventional glycaemic controlAlso: Control groupConventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%. | Drug | Conventional glycaemic control (Control) |
Primary outcome
Nosocomial Infection
Time frame: within the first 30 day after surgery
Infection rate referred to the rate of nosocomial infection, including pneumonia, central line infection, surgical wound infection, deep sternal wound infection, urinary tract infection, and sepsis. Infections were defined according to the Centers for Disease Control and Prevention (CDC) definitions, occurring within 30 days postoperative cardiac surgery.
1 secondary outcome
Morbidities and All Causes Mortality
Time frame: within the first 30 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Panthila Rujirojindakul, M.D. principal investigator
Faculty of Medicine, Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TGC in people with Nosocomial Infection and External Causes of Morbidity and Mortality, run by Prince of Songkla University at 1 site in Thailand.
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 3 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 18 Dec 2015. 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 Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Nosocomial Infection (time frame: within the first 30 day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2015.