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

Not Applicable

Not yet recruiting

• Conditions: Validation of Minute Bundle in Undifferntiated Shock

• Registration Number: NCT07209735
• Lead Sponsor: Assiut University

Brief Summary

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 Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-30
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study Start: 2025-10-01
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Primary Completion: 2027-10
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Shock reversal within 6 hours (MAP ≥65 mmHg without vasopressors + improved perfusion)	Minute bundle in initial 30-minute management Shock reversal within 6 hours