Respiratory Distress Syndrome, AdultPhase 2NCT00605696
Early Insulin and Development of ARDS
A Phase 2 study testing Insulin in people with Respiratory Distress Syndrome, Adult and Sepsis, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) is a severe lung condition that causes respiratory failure. Symptoms usually develop within 24 to 48 hours of an original injury or illness, and people with ALI/ARDS typically require care in the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Sepsis, 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
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Sep 2013
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with severe sepsis, which is defined as sepsis AND one or more signs of organ dysfunction or hypotension
- Hyperglycemia (i.e., glucose level greater than 130 mg/dL on one or more tests)
Who cannot join
- Diabetic ketoacidosis
- Severe chronic liver disease with Child-Pugh score greater than 10 (Class C)
- Documented episodes of blood or plasma glucose less than 60 mg/dL within 24 hours of study entry
- Lack of any available IV access for insulin infusion
- Pregnant
- Known advanced directives against intubation or aggressive ICU care
- Inability to be enrolled into the study in the 12 hours following admission to the ED
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Early Insulin Therapy and Development of Acute Respiratory Distress Syndrome
Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) is a severe lung condition that causes respiratory failure. Symptoms usually develop within 24 to 48 hours of an original injury or illness, and people with ALI/ARDS typically require care in the intensive care unit (ICU). Little is known about how to prevent the onset of ALI/ARDS. The purpose of this study is to examine if early infusions of insulin, known as intensive insulin therapy (IIT), can help prevent ALI/ARDS in hospitalized patients with high levels of blood sugars and severe infections.
Read the detailed description
ALI/ARDS is a life-threatening condition that involves inflammation of the lungs and fluid accumulation in the air sacs, leading to low blood oxygen levels and respiratory failure. Common causes include pneumonia, lung trauma, and sepsis, a condition that can lead to widespread inflammation and blood clotting in response to an infection. Recent studies have shown that insulin, which is regularly used to control blood sugar levels, may prevent or lessen the risk of lung tissue inflammation and/or lung injury related to sepsis. Research has shown that critically ill ICU patients often benefit from receiving insulin to target 80-110 mg/dl , but it is not known if insulin to target these levels can prevent the onset of ALI/ARDS. Therapies to prevent ALI/ARDS should occur early, preferably even prior to ICU admission, because at least 38% of people with ALI/ARDS are diagnosed with the condition once they reach the ICU. The purpose of this study is to determine whether insulin to target 80-110 mg/dl administered to critically ill patients in the emergency department (ED) is more beneficial at preventing ALI/ARDS than insulin to target 150-180 mg/dl after ICU admission.
This study will enroll people who are hospitalized with high blood sugar levels and severe sepsis. Participants will be randomly assigned to receive IIT within 6-12 hours of ED presentation to target 80-110 mg/dl or target 150-180 mg/dl for 48 hours after admission to the ICU followed by usual care. Prior to ICU admission and 1, 3, and 7 days after ICU admission, blood will be collected and analyzed for markers of inflammation and lung injury. Blood samples will be stored for future research studies. While participants are in the hospital, their medical records will be reviewed to gather information on medical and family history, demographics, vital signs, laboratory test results, x-ray findings, and lung function. Study researchers will also monitor participants for the development of severe lung failure or other organ failures.
- Conditions
- Respiratory Distress Syndrome, Adult, Sepsis, Hyperglycemia
- Being tested
- Insulin
- Keywords
- Acute Respiratory Distress Syndrome, Acute Lung Injury
- Medical subject headings
- Respiratory Distress Syndrome, Sepsis, Hyperglycemia, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) for up to 48 hours after ICU admission.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive insulin to target glucose 80-110 mg/dl within 6-12 hours after presenting to ED. Receives: Drug: Insulin |
| 2 | Active comparator | Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Levels of Free Fatty Acids, Tumor Necrosis Factor-α, Interleukin-6, and Von Willebrand Factor Antigen
Measured: Measured at Day 1, 3 and 7
Secondary outcomes (1)
Murray Lung Injury Score
Murray Lung Injury Score is a continuous score that quantifies the severity of lung injury and consist of components related to severity of hypoxia, pulmonary compliance, peep, and radiologic abnormalities. The scores range between 0 - 4. The higher the score, the greater the degree and severity of lung injury. The scale runs from 0-4, with 0 being the minimum and 4 the maximum score.
Measured: Measured at Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2011
- Study completionSep 2013
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 Respiratory Distress Syndrome, AdultStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Michelle Gong, Albert Einstein College of Medicine
- Investigators
- Michelle Ng Gong, MD, MS, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605696
- Sponsor's protocol ID
- 2009-462
- Other IDs
- R01HL086667
- Status last verified
- Apr 2018
- First submitted
- 18 Jan 2008
- Last updated
- 7 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Insulin Therapy and Development of Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT00605696
- Acronym / sponsor ID
- 2009-462
- Conditions
- Respiratory Distress Syndrome, Adult, Sepsis, Hyperglycemia
- Keywords
- Acute Respiratory Distress Syndrome, Acute Lung Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 31 Jan 2008 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) is a severe lung condition that causes respiratory failure. Symptoms usually develop within 24 to 48 hours of an original injury or illness, and people with ALI/ARDS typically require care in the intensive care unit (ICU). Little is known about how to prevent the onset of ALI/ARDS. The purpose of this study is to examine if early infusions of insulin, known as intensive insulin therapy (IIT), can help prevent ALI/ARDS in hospitalized patients with high levels of blood sugars and severe infections.
Detailed description
ALI/ARDS is a life-threatening condition that involves inflammation of the lungs and fluid accumulation in the air sacs, leading to low blood oxygen levels and respiratory failure. Common causes include pneumonia, lung trauma, and sepsis, a condition that can lead to widespread inflammation and blood clotting in response to an infection. Recent studies have shown that insulin, which is regularly used to control blood sugar levels, may prevent or lessen the risk of lung tissue inflammation and/or lung injury related to sepsis. Research has shown that critically ill ICU patients often benefit from receiving insulin to target 80-110 mg/dl , but it is not known if insulin to target these levels can prevent the onset of ALI/ARDS. Therapies to prevent ALI/ARDS should occur early, preferably even prior to ICU admission, because at least 38% of people with ALI/ARDS are diagnosed with the condition once they reach the ICU. The purpose of this study is to determine whether insulin to target 80-110 mg/dl administered to critically ill patients in the emergency department (ED) is more beneficial at preventing ALI/ARDS than insulin to target 150-180 mg/dl after ICU admission.
This study will enroll people who are hospitalized with high blood sugar levels and severe sepsis. Participants will be randomly assigned to receive IIT within 6-12 hours of ED presentation to target 80-110 mg/dl or target 150-180 mg/dl for 48 hours after admission to the ICU followed by usual care. Prior to ICU admission and 1, 3, and 7 days after ICU admission, blood will be collected and analyzed for markers of inflammation and lung injury. Blood samples will be stored for future research studies. While participants are in the hospital, their medical records will be reviewed to gather information on medical and family history, demographics, vital signs, laboratory test results, x-ray findings, and lung function. Study researchers will also monitor participants for the development of severe lung failure or other organ failures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: InsulinParticipants will receive insulin to target glucose 80-110 mg/dl within 6-12 hours after presenting to ED. |
| 2 | Active comparator | Drug: InsulinParticipants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with severe sepsis, which is defined as sepsis AND one or more signs of organ dysfunction or hypotension
- Hyperglycemia (i.e., glucose level greater than 130 mg/dL on one or more tests)
Key exclusion criteria (7 listed)
- Diabetic ketoacidosis
- Severe chronic liver disease with Child-Pugh score greater than 10 (Class C)
- Documented episodes of blood or plasma glucose less than 60 mg/dL within 24 hours of study entry
- Lack of any available IV access for insulin infusion
- 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 |
|---|---|---|
| InsulinParticipants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) for up to 48 hours after ICU admission. | Drug | 1, 2 |
Primary outcome
Plasma Levels of Free Fatty Acids, Tumor Necrosis Factor-α, Interleukin-6, and Von Willebrand Factor Antigen
Time frame: Measured at Day 1, 3 and 7
1 secondary outcome
Murray Lung Injury Score
Time frame: Measured at Day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Michelle Ng Gong, MD, MS principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Insulin in people with Respiratory Distress Syndrome, Adult and Sepsis, run by Albert Einstein College of Medicine at 1 site in United States.
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 7 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 7 May 2018. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2017). 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?
Plasma Levels of Free Fatty Acids, Tumor Necrosis Factor-α, Interleukin-6, and Von Willebrand Factor Antigen (time frame: Measured at Day 1, 3 and 7). 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 7 May 2018.