Stress HyperglycemiaNCT04408768
Stress Hyperglycemia and Acute Ischemic Stroke
An observational study of Stress Hyperglycemia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Whereas diabetes mellitus is clearly a risk factor for the occurrence of stroke and for its poor prognosis, hyperglycemia per se is also linked to increased morbidity and mortality in stroke patients.Therefore, the objective of this work was to study the glycemic status of acute ischemic stroke patients and to assess… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Stress Hyperglycemia
- What is being tested?
- standard protocol for stroke patients
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 17 May 2018to 20 Aug 2019
- Phase
- Observational
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study included eighty acute ischemic stroke patients who presented within 24 hours of onset of symptoms. They were equally divided into two groups; group A included patients with normal (70-150 mg/dl) RBS on ICU admission and controlled blood sugar within 24 h, while group B included those with high RBS on ICU admission and uncontrolled blood sugar during first 24 h.
Who may be able to join
- Acute ischemic stroke within 24 hours of onset of symptoms
Who cannot join
- subdural hematoma
- Transient ischemic attack
- Subarachnoid hemorrhage
- Hemorrhagic stroke
- Major comorbidities Hyperglycemia on admission that was controlled (random blood sugar (RBS) < 150 mg/dl) within 24 hours with insulin therapy, diabetic
- Ketoacidosis
- RBS less than 70 mg/dl on admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress Hyperglycemia as a Prognostic Factor in Acute Ischemic Stroke Patients
Whereas diabetes mellitus is clearly a risk factor for the occurrence of stroke and for its poor prognosis, hyperglycemia per se is also linked to increased morbidity and mortality in stroke patients.Therefore, the objective of this work was to study the glycemic status of acute ischemic stroke patients and to assess its impact on stroke outcome.
Read the detailed description
Using PASS program, setting alpha error at 5% and power of 80%, the total sample size was estimated to be 80 cases.
The NIHSS was used as a primary outcome; 40 cases were needed in each group. Secondary outcomes were hemorrhagic transformation, hospital stay duration, mechanical ventilation, need for vasopressors, and 30-days mortality.
- Conditions
- Stress Hyperglycemia
- Being tested
- standard protocol for stroke patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard protocol for stroke patientsOther
Also called no specific intervention
Standard protocol for stroke patients
| Study group | Role | What they receive |
|---|---|---|
| Normal RBS | Normal RBS on ICU admission and controlled blood sugar within 24 hours Receives: Other: standard protocol for stroke patients | |
| High RBS | High RBS on ICU admission and uncontrolled blood sugar during first 24 hours Receives: Other: standard protocol for stroke patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health Stroke Scale (NIHSS)
The NIHSS score categorized into: no stroke symptoms (0), mild stroke (1-4), moderate stroke (5-15), moderate to severe stroke (16-20), and sever (21-42)
Measured: 30 days
Secondary outcomes (1)
30-days mortality
Hemorrhagic transformation, the length of hospital stay, need for mechanical ventilation and vasopressors and 30-days mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start17 May 2018
- Primary completion9 Jul 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress HyperglycemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Mohamed Abdallah ElGendy MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408768
- Sponsor's protocol ID
- El Zaiton Specialized Hospital
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Hyperglycemia as a Prognostic Factor in Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT04408768
- Acronym / sponsor ID
- El Zaiton Specialized Hospital
- Conditions
- Stress Hyperglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 29 May 2020 (actual)
- 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.
Whereas diabetes mellitus is clearly a risk factor for the occurrence of stroke and for its poor prognosis, hyperglycemia per se is also linked to increased morbidity and mortality in stroke patients.Therefore, the objective of this work was to study the glycemic status of acute ischemic stroke patients and to assess its impact on stroke outcome.
Detailed description
Using PASS program, setting alpha error at 5% and power of 80%, the total sample size was estimated to be 80 cases.
The NIHSS was used as a primary outcome; 40 cases were needed in each group. Secondary outcomes were hemorrhagic transformation, hospital stay duration, mechanical ventilation, need for vasopressors, and 30-days mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal RBS | – | Other: standard protocol for stroke patientsNormal RBS on ICU admission and controlled blood sugar within 24 hours |
| High RBS | – | Other: standard protocol for stroke patientsHigh RBS on ICU admission and uncontrolled blood sugar during first 24 hours |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included eighty acute ischemic stroke patients who presented within 24 hours of onset of symptoms. They were equally divided into two groups; group A included patients with normal (70-150 mg/dl) RBS on ICU admission and controlled blood sugar within 24 h, while group B included those with high RBS on ICU admission and uncontrolled blood sugar during first 24 h.
Key inclusion criteria (1 listed)
- Acute ischemic stroke within 24 hours of onset of symptoms
Key exclusion criteria (7 listed)
- subdural hematoma
- Transient ischemic attack
- Subarachnoid hemorrhage
- Hemorrhagic stroke
- Major comorbidities Hyperglycemia on admission that was controlled (random blood sugar (RBS) < 150 mg/dl) within 24 hours with insulin therapy, diabetic
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 |
|---|---|---|
| standard protocol for stroke patientsAlso: no specific interventionStandard protocol for stroke patients | Other | High RBS, Normal RBS |
Primary outcome
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 30 days
The NIHSS score categorized into: no stroke symptoms (0), mild stroke (1-4), moderate stroke (5-15), moderate to severe stroke (16-20), and sever (21-42)
1 secondary outcome
30-days mortality
Time frame: 30 days
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 1 Jun 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Stress Hyperglycemia
Active, not recruiting
The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes
Hyperglycemia, Dyslipidemias
Not yet recruitingObservational study
The Prevalence of Hyperglycemia in Surgical Patients With Pre-diabetes
Prediabetes or Diabetes, Surgery Complications
Not yet recruiting
Closed Loop Glucose Control in a Simulated ICU Setting
Type 1 Diabetes, Type 2 Diabetes
Recruiting
Diabetes Clinical Decision Support
Hyperglycemia, Hyperglycemia Stress
RecruitingObservational study
Metabolic Control in Anesthesia and Surgery
Anesthesia, Continuous Glucose Monitoring
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Hyperglycemia, run by Ain Shams University at 1 site in Egypt.
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 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 1 Jun 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 Egypt. 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.
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?
National Institutes of Health Stroke Scale (NIHSS) (time frame: 30 days). 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 1 Jun 2020.