HypoglycemiaPhase 4NCT01387477
Lactate to Treat Hypoglycemia
A Phase 4 study testing Lactate and Glucose in people with Hypoglycemia, run by Institut d'Anesthesiologie des Alpes Maritimes at 1 site in France.
Trial summary
Tight glucose control in intensive care has become a major concern, allowing a reduction in morbidity and mortality. However, its use is limited by the percentage of hypoglycemia which can have severe consequences on the brain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Lactate and Glucose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Jun 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hypoglycemia under 0.6 g/L
Who cannot join
- hepatic failure
- hyperlactatemia above 5 mmol/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Strategies of Hypoglycemia Correction in ICU
Tight glucose control in intensive care has become a major concern, allowing a reduction in morbidity and mortality. However, its use is limited by the percentage of hypoglycemia which can have severe consequences on the brain. The bispectral index (BIS) is derived from the EEG and measures of brain electrical activity noninvasively. It has already been shown that its value changes according to hypoglycemia and its correction. Furthermore, if the hormonal response to hypoglycemia is well known in healthy and diabetic subjects, it is not the case in ICU patient. The usual treatment of hypoglycemia is based on parenteral infusion of glucose. Btu this can lead to a hyperglycemic rebound that can be deleterious. Lactate is a substrate for gluconeogenesis and an energy substrate during critical situations. It has been shown to improve neurological tests during hypoglycaemia and had cerebral protective properties after a severe head injury. The hypothesis of this study is that sodium lactate is superior than the 30% glucose to correct hypoglycemia in the ICU in terms of glycemic variation, brain function and hormonal response.
- Conditions
- Hypoglycemia
- Being tested
- Lactate, Glucose
- Keywords
- hypoglycemia, lactate, glucose, ICU
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactateDrug
Infusion of 66 mmol of lactate
GlucoseDrug
Infusion of 33 mmol of glucose
| Study group | Role | What they receive |
|---|---|---|
| Lactate | Experimental | infusion of 66 mmol of lactate Receives: Drug: Lactate |
| glucose | Active comparator | infusion of 33 mmol of glucose Receives: Drug: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of the glycemia
Measured: 30 minutes
Secondary outcomes (4)
Bispectral index variation
Measured: 60 minutes
Maximum change in glycemia
Measured: 30 minutes
Changes in growth hormone and cortisol
Measured: 180 minutes
Need for glucose infusion for persistent hypoglycemia
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startJun 2011 (estimated)
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies 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
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut d'Anesthesiologie des Alpes Maritimes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor C ICHAI, Institut d'Anesthesiologie des Alpes Maritimes
- Investigators
- Jean-Christophe Orban, MD, Principal investigator, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387477
- Sponsor's protocol ID
- IAAM 2011-01
- Status last verified
- Jul 2020
- First submitted
- 30 Jun 2011
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Strategies of Hypoglycemia Correction in ICU
- ClinicalTrials.gov ID
- NCT01387477
- Acronym / sponsor ID
- IAAM 2011-01
- Conditions
- Hypoglycemia
- Keywords
- hypoglycemia, lactate, glucose, ICU
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut d'Anesthesiologie des Alpes MaritimesUniversity, hospital or other
- Study start
- Jun 2011 (estimated)
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 4 Jul 2011 (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.
Tight glucose control in intensive care has become a major concern, allowing a reduction in morbidity and mortality. However, its use is limited by the percentage of hypoglycemia which can have severe consequences on the brain. The bispectral index (BIS) is derived from the EEG and measures of brain electrical activity noninvasively. It has already been shown that its value changes according to hypoglycemia and its correction. Furthermore, if the hormonal response to hypoglycemia is well known in healthy and diabetic subjects, it is not the case in ICU patient. The usual treatment of hypoglycemia is based on parenteral infusion of glucose. Btu this can lead to a hyperglycemic rebound that can be deleterious. Lactate is a substrate for gluconeogenesis and an energy substrate during critical situations. It has been shown to improve neurological tests during hypoglycaemia and had cerebral protective properties after a severe head injury. The hypothesis of this study is that sodium lactate is superior than the 30% glucose to correct hypoglycemia in the ICU in terms of glycemic variation, brain function and hormonal response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactate | Experimental | Drug: Lactateinfusion of 66 mmol of lactate |
| glucose | Active comparator | Drug: Glucoseinfusion of 33 mmol of glucose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hypoglycemia under 0.6 g/L
Key exclusion criteria (2 listed)
- hepatic failure
- hyperlactatemia above 5 mmol/L
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 |
|---|---|---|
| LactateInfusion of 66 mmol of lactate | Drug | Lactate |
| GlucoseInfusion of 33 mmol of glucose | Drug | glucose |
Primary outcome
Area under the curve of the glycemia
Time frame: 30 minutes
4 secondary outcomes
Bispectral index variation
Time frame: 60 minutes
Maximum change in glycemia
Time frame: 30 minutes
Changes in growth hormone and cortisol
Time frame: 180 minutes
Need for glucose infusion for persistent hypoglycemia
Time frame: 30 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
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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.
Jean-Christophe Orban, MD principal investigator
Nice University Hospital
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 Lactate and Glucose in people with Hypoglycemia, run by Institut d'Anesthesiologie des Alpes Maritimes at 1 site in France.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 31 Jul 2020. 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 France. 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 was withdrawn before enrolling participants, so there are no results.
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?
Area under the curve of the glycemia (time frame: 30 minutes). 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 31 Jul 2020.