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NCT Number: NCT07209735

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

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

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Key information

Conditions

Validation of Minute Bundle in Undifferntiated Shock

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1. 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

Exclusion criteria

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

Treatment and study plan

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Omnia Esaam Abdelhady

CONTACT

[email protected]

01142317240

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Oct 7, 2025
Registry last updated: Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.