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New treatment option for Hemodynamics Instability
Official title Non-invasive Goal-directed thErapy oN cIrcUlatory Shock
ClinicalTrials.gov ID: NCT05336357
What this study is testing
- What it's testing
- Circulatory shock occurs when the oxygen supply to the tissues decreases, leading to cellular damage and affecting about one-third of patients admitted to Intensive Care Units (ICUs). Cardiac Output (CO) is defined as the volume of blood ejected by the left ventricle per minute and is a crucial hemodynamic parameter for monitoring patients with signs of circulatory shock.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \> 18 years;
- Patients admitted to Emergency Units, Intensive Care Units, and Wards within 3 hours of the diagnosis of Septic Shock:
- Systolic Blood Pressure (SBP) \< 90 mmHg and/or Mean Arterial Pressure (MAP) \< 65 mmHg (with or without norepinephrine at a dose less than 0.5...
- Lactate \> 2 mEq/L;
- Oliguria (urine output \< 0.5 mL/kg/h for at least 6 hours);
You likely can't join if
- Hospital admission time greater than 24 hours
- Significant edema in the fingers
- Severe peripheral vasoconstriction
- Use of Norepinephrine at a dose greater than or equal to 0.5 mcg/kg/min
- Presence of significant Aortic Insufficiency
- Patients undergoing Renal Replacement Therapy
See the full eligibility criteria
- Age \> 18 years;
- Patients admitted to Emergency Units, Intensive Care Units, and Wards within 3 hours of the diagnosis of Septic Shock:
- Systolic Blood Pressure (SBP) \< 90 mmHg and/or Mean Arterial Pressure (MAP) \< 65 mmHg (with or without norepinephrine at a dose less than 0.5 mcg/kg/min) + Clinical signs of infection and at least one of the following:
- Lactate \> 2 mEq/L;
- Oliguria (urine output \< 0.5 mL/kg/h for at least 6 hours);
- Neurological changes (mental confusion, decreased level of consciousness, psychomotor agitation, temporal-spatial disorientation);
- Capillary refill time \> 3 s (after digital compression for 10 seconds);
- Poor skin perfusion.
- Signed Informed Consent Form.
- Hospital admission time greater than 24 hours
- Significant edema in the fingers
- Severe peripheral vasoconstriction
- Use of Norepinephrine at a dose greater than or equal to 0.5 mcg/kg/min
- Presence of significant Aortic Insufficiency
- Patients undergoing Renal Replacement Therapy
- Patients with ST-segment elevation Myocardial Infarction
- Patients requiring Invasive Mechanical Ventilation
- Patients already participating in another study
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, Brazil
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.