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Not yet recruiting NCT07209735

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

No phase Interventional Validation of Minute Bundle in Undifferntiated Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound.
Who it may be relevant to
Registry conditions: Validation of Minute Bundle in Undifferntiated Shock. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Device Ultrasound
    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 stabilizati

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07209735 · MINUTES-SHOCK-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗