Effectiveness of the MINUTES Bundle for Initial 30-Minute Management of Undifferentiated Circulatory Shock in the Emergency Department
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 202
- Primary Endpoint
- Shock reversal within 6 hours (MAP ≥65 mmHg without vasopressors + improved perfusion)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •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
Arms & Interventions
Participants will receive the Minute Bundle, a structured package of early resuscitation interventio
Intervention: Ultrasound (Device)
Participants will receive standard resuscitation according to current institutional protocols and tr
Intervention: Ultrasound (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Omnia Esaam Abdelhady
Effectiveness of the MINUTES Bundle for Initial 30-Minute Management of Undifferentiated Circulatory Shock in the Emergency Department
Assiut University