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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07209735

Enrollment

202

Registered

2025-10-07

Start date

2025-12-20

Completion date

2027-10-20

Last updated

2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Validation of Minute Bundle in Undifferntiated Shock

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

Interventions

DEVICEUltrasound

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.

Study design

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.

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Contacts

CONTACTOmnia Esaam Abdelhady

omniaesaam677@gmail.com01142317240

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026