Effectiveness of the MINUTES Bundle for Initial 30-Minute Management of Undifferentiated Circulatory Shock in the Emergency Department

NCT07209735 | Not Yet Recruiting

• 1 other identifier: MINUTES-SHOCK-2025
• Study Type: interventional
• Target: 202
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to validate the effectiveness of the MINUTES bundle on clinical outcomes in patients presenting with undifferentiated shock.

Conditions

Validation of Minute Bundle in Undifferntiated Shock

Outcome Measures

Primary Outcomes (1)

• Shock reversal within 6 hours (MAP ≥65 mmHg without vasopressors + improved perfusion)

  Minute bundle in initial 30-minute management Shock reversal within 6 hours

Study Arms (2)

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

Interventions

Ultrasound DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adults 18-65 years old
• \. 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

You may not qualify if:

• Trauma-related shock 2- Known terminal illness- Transferred after prior resuscitation 4- Pregnant patients 5-Patients with cardiac arrest upon arrival

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Omnia Esaam Abdelhady

CONTACT

01142317240; omniaesaam677@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial. Due to the nature of the intervention (implementation of the MINUTES bundle in the emergency department), blinding of participants, care providers, and investigators is not feasible.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effectiveness of the MINUTES Bundle for Initial 30-Minute Management of Undifferentiated Circulatory Shock in the Emergency Department

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 7, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 20, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01