Mild Therapeutic HypothermiaNCT06947616
Effect of Mild Therapeutic Hypothermia on the Doses of Vasopressors and Inotropes in Cardiogenic Shock Complicating Acute Myocardial Infarction
A study testing Mild therapeutic hypothermia in people with Mild Therapeutic Hypothermia and Cardiogenic Shock, run by Tanta University at 1 site in Egypt.
Trial summary
The study aimed to assess the effects of mild therapeutic hypothermia (MTH) on vasopressors and inotropes in patients with cardiogenic shock (CS) due to acute myocardial infarction (AMI). Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Mild Therapeutic Hypothermia, Cardiogenic Shock, Acute Myocardial Infarction
- What is being tested?
- Mild therapeutic hypothermia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Oct 2022
- Phase
- Interventional
- 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
Who may be able to join
- Age from 50 to 70 years.
- Both sexes.
- Cardiogenic shock post AMI defined by systolic blood pressure <90 mm Hg for >30 minutes or motropes required to maintain a systolic blood pressure >90 mm Hg in the absence of hypovolemia with signs of pulmonary congestion and signs of impaired organ perfusion defined by at least 1 of the following: altered mental status; cold, clammy skin; urine output <30 mL/h; or arterial lactate >2 mmol/L.
- 2. Intubated and sedated
Who cannot join
- Self-ventilated
- Indication for targeted temperature management by current guidelines "out of hospital cardiac arrest with return of spontaneous circulation (ROSC)"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mild Therapeutic Hypothermia on the Doses of Vasopressors and Inotropes in Cardiogenic Shock Complicating Acute Myocardial Infarction: A Randomized Controlled Trial
The study aimed to assess the effects of mild therapeutic hypothermia (MTH) on vasopressors and inotropes in patients with cardiogenic shock (CS) due to acute myocardial infarction (AMI).
Read the detailed description
Cardiogenic shock (CS) is a condition characterized by a severe lack of blood flow to vital organs caused by primary malfunction of the heart, as described by the European Society of Cardiology (ESC) and the American Heart Association (AHA). Acute myocardial infarction (AMI) is a prevalent etiology of CS, constituting a minimum of 30% of the instances. 50% of CS cases manifest upon hospital admission, whereas the remaining 50% occur after hospital admission.
- Conditions
- Mild Therapeutic Hypothermia, Cardiogenic Shock, Acute Myocardial Infarction, Vasopressors, Inotropes
- Being tested
- Mild therapeutic hypothermia
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mild therapeutic hypothermiaDrug
Patients received mild therapeutic hypothermia (MTH) to 33°C for 24-36 h
| Study group | Role | What they receive |
|---|---|---|
| Mild therapeutic hypothermia group | Experimental | Patients received mild therapeutic hypothermia (MTH) to 33°C for 24-36 h Receives: Drug: Mild therapeutic hypothermia |
| Control group | No intervention | Patients did not receive mild therapeutic hypothermia (MTH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of stroke
Incidence of stroke until day 30 was recorded.
Measured: 30 day after the procedure
Secondary outcomes (4)
Duration of mechanical ventilation
Duration of mechanical ventilation was recorded.
Measured: Up to 7 days
Length of intensive care unit stay
Length of intensive care unit (ICU) stay refers to the total duration a patient remains in the ICU, beginning from the moment of admission to the ICU until their discharge or transfer to a less intensive care setting, such as a regular hospital ward or home.
Measured: Up to 2 weeks after the procedure
Duration of inotropic support
Duration of inotropic support was recorded.
Measured: Intraoperatively
Incidence of mortality
Incidence of mortality was recorded.
Measured: 30 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Oct 2020
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Therapeutic HypothermiaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelrazek Abdelmonem Abdelaal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947616
- Sponsor's protocol ID
- 33716/3/20
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mild Therapeutic Hypothermia on the Doses of Vasopressors and Inotropes in Cardiogenic Shock Complicating Acute Myocardial Infarction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06947616
- Acronym / sponsor ID
- 33716/3/20
- Conditions
- Mild Therapeutic Hypothermia, Cardiogenic Shock, Acute Myocardial Infarction, Vasopressors, Inotropes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 27 Apr 2025 (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.
The study aimed to assess the effects of mild therapeutic hypothermia (MTH) on vasopressors and inotropes in patients with cardiogenic shock (CS) due to acute myocardial infarction (AMI).
Detailed description
Cardiogenic shock (CS) is a condition characterized by a severe lack of blood flow to vital organs caused by primary malfunction of the heart, as described by the European Society of Cardiology (ESC) and the American Heart Association (AHA). Acute myocardial infarction (AMI) is a prevalent etiology of CS, constituting a minimum of 30% of the instances. 50% of CS cases manifest upon hospital admission, whereas the remaining 50% occur after hospital admission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild therapeutic hypothermia group | Experimental | Drug: Mild therapeutic hypothermiaPatients received mild therapeutic hypothermia (MTH) to 33°C for 24-36 h |
| Control group | No intervention | –Patients did not receive mild therapeutic hypothermia (MTH) |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 50 to 70 years.
- Both sexes.
- Cardiogenic shock post AMI defined by systolic blood pressure <90 mm Hg for >30 minutes or motropes required to maintain a systolic blood pressure >90 mm Hg in the absence of hypovolemia with signs of pulmonary congestion and signs of impaired organ perfusion defined by at least 1 of the following: altered mental status; cold, clammy skin; urine output <30 mL/h; or arterial lactate >2 mmol/L.
- 2. Intubated and sedated
Key exclusion criteria (2 listed)
- Self-ventilated
- Indication for targeted temperature management by current guidelines "out of hospital cardiac arrest with return of spontaneous circulation (ROSC)"
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 |
|---|---|---|
| Mild therapeutic hypothermiaPatients received mild therapeutic hypothermia (MTH) to 33°C for 24-36 h | Drug | Mild therapeutic hypothermia group |
Primary outcome
Incidence of stroke
Time frame: 30 day after the procedure
Incidence of stroke until day 30 was recorded.
4 secondary outcomes
Duration of mechanical ventilation
Time frame: Up to 7 days
Length of intensive care unit stay
Time frame: Up to 2 weeks after the procedure
Duration of inotropic support
Time frame: Intraoperatively
Incidence of mortality
Time frame: 30 days after the procedure
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 27 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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?
A study testing Mild therapeutic hypothermia in people with Mild Therapeutic Hypothermia and Cardiogenic Shock, run by Tanta 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 4 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: finished, as of the sponsor's last update on 27 Apr 2025. 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?
Incidence of stroke (time frame: 30 day after the procedure). 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 27 Apr 2025.