Validation of Minute Bundle in Undifferntiated ShockNCT07209735
Effectiveness of the MINUTES Bundle for Initial 30-Minute Management of Undifferentiated Circulatory Shock in the Emergency Department
A study testing Ultrasound in people with Validation of Minute Bundle in Undifferntiated Shock, run by Assiut University.
Trial summary
This study aims to validate the effectiveness of the MINUTES bundle on clinical outcomes in patients presenting with undifferentiated shock. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Validation of Minute Bundle in Undifferntiated Shock
- What is being tested?
- Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 20 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adults 18-65 years old
- 2. Clinical signs of circulatory shock:
- SBP <90 mmHg or MAP <65 mmHg
- Signs of hypoperfusion (altered mental status, oliguria, elevated lactate) 3. No clear etiology of shock at time of triage
Who cannot join
- 1- Trauma-related shock 2- Known terminal illness- Transferred after prior resuscitation 4- Pregnant patients 5-Patients with cardiac arrest upon arrival
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to validate the effectiveness of the MINUTES bundle on clinical outcomes in patients presenting with undifferentiated shock.
Read the detailed description
Undifferentiated circulatory shock represents a critical challenge in emergency medicine (1), requiring rapid assessment and immediate intervention to prevent organ failure and death. Early goal-directed therapy (EGDT) and time-sensitive bundles have proven beneficial in improving outcomes. While specific shock types (e.g., septic, cardiogenic) have established guidelines (2-6), there is limited structured guidance for the initial 30-minute management "golden half hour" of resuscitation when the cause is unknown.
The MINUTES bundle, proposed in recent expert opinion (7), offers a structured approach to streamline early resuscitation and evaluation steps. It includes:
- Maintain ABCs (airway, breathing, circulation)
- INfuse vasopressors/fluids and INvestigate basic labs
- Ultrasound (POCUS)
- Treat underlying Etiology
- Stabilize systemic perfusion
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Participants in this arm will receive the structured MINUTES bundle during the first 30 minutes of shock management in the emergency department. The bundle includes: continuous monitoring, intravenous access and fluid resuscitation, early initiation of norepinephrine when indicated, point-of-care ultrasound assessment (cardiac, IVC, and lung ultrasound) to guide diagnosis and resuscitation, essential laboratory tests, early antibiotics if infection is suspected, and source control or stabilization measures.
| Study group | Role | What they receive |
|---|---|---|
| Participants will receive the Minute Bundle, a structured package of early resuscitation interventio | Experimental | Not described Receives: Device: Ultrasound |
| Participants will receive standard resuscitation according to current institutional protocols and tr | Active comparator | Not described Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shock reversal within 6 hours (MAP ≥65 mmHg without vasopressors + improved perfusion)
Measured: Minute bundle in initial 30-minute management Shock reversal within 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start20 Dec 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completion20 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation of Minute Bundle in Undifferntiated ShockStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The intervention group will receive the MINUTES bundle for the initial 30-minute management of undifferentiated circulatory shock in the emergency department, while the control group will receive standard care according to current departmental protocols. Outcomes will be compared between both groups to evaluate the effectiveness of the MINUTES bundle.
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Esaam Abdelhady, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209735
- Sponsor's protocol ID
- MINUTES-SHOCK-2025
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the MINUTES Bundle for Initial 30-Minute Management of Undifferentiated Circulatory Shock in the Emergency Department
- ClinicalTrials.gov ID
- NCT07209735
- Acronym / sponsor ID
- MINUTES-SHOCK-2025
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- 20 Oct 2027 (estimated)
- First posted
- 7 Oct 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.
This study aims to validate the effectiveness of the MINUTES bundle on clinical outcomes in patients presenting with undifferentiated shock.
Detailed description
Undifferentiated circulatory shock represents a critical challenge in emergency medicine (1), requiring rapid assessment and immediate intervention to prevent organ failure and death. Early goal-directed therapy (EGDT) and time-sensitive bundles have proven beneficial in improving outcomes. While specific shock types (e.g., septic, cardiogenic) have established guidelines (2-6), there is limited structured guidance for the initial 30-minute management "golden half hour" of resuscitation when the cause is unknown.
The MINUTES bundle, proposed in recent expert opinion (7), offers a structured approach to streamline early resuscitation and evaluation steps. It includes:
- Maintain ABCs (airway, breathing, circulation)
- INfuse vasopressors/fluids and INvestigate basic labs
- Ultrasound (POCUS)
- Treat underlying Etiology
- Stabilize systemic perfusion
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The intervention group will receive the MINUTES bundle for the initial 30-minute management of undifferentiated circulatory shock in the emergency department, while the control group will receive standard care according to current departmental protocols. Outcomes will be compared between both groups to evaluate the effectiveness of the MINUTES bundle.
| Arm | Type | Receives |
|---|---|---|
| Participants will receive the Minute Bundle, a structured package of early resuscitation interventio | Experimental | Device: Ultrasound |
| Participants will receive standard resuscitation according to current institutional protocols and tr | Active comparator | Device: Ultrasound |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Adults 18-65 years old
Key exclusion criteria (1 listed)
- 1- Trauma-related shock 2- Known terminal illness- Transferred after prior resuscitation 4- Pregnant patients 5-Patients with cardiac arrest upon arrival
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 |
|---|---|---|
| UltrasoundParticipants in this arm will receive the structured MINUTES bundle during the first 30 minutes of shock management in the emergency department. The bundle includes: continuous monitoring, intravenous access and fluid resuscitation, early initiation of norepinephrine when indicated, point-of-care ultrasound assessment (cardiac, IVC, and lung ultrasound) to guide diagnosis and resuscitation, essential laboratory tests, early antibiotics if infection is suspected, and source control or stabilization measures. | Device | Participants will receive standard resuscitation according to current institutional protocols and tr, Participants will receive the Minute Bundle, a structured package of early resuscitation interventio |
Primary outcome
Shock reversal within 6 hours (MAP ≥65 mmHg without vasopressors + improved perfusion)
Time frame: Minute bundle in initial 30-minute management Shock reversal within 6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Validation of Minute Bundle in Undifferntiated Shock, run by Assiut University.
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 1 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: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omnia Esaam Abdelhady (01142317240, omniaesaam677@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shock reversal within 6 hours (MAP ≥65 mmHg without vasopressors + improved perfusion) (time frame: Minute bundle in initial 30-minute management Shock reversal within 6 hours). 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 16 Jan 2026.