RApid Fluid Volume EXpansion in Patients in Shock After the Initial Phase of Resuscitation.

Launched by CENTRE HOSPITALIER RÉGIONAL D'ORLÉANS · Jan 4, 2016

Keywords

ClinConnect Summary

This clinical trial is studying how to improve treatment for patients in shock, which is a serious condition where the body doesn't get enough blood flow. The researchers want to see if using a specific test called the Passive Leg Raising (PLR) test can help decide when to give patients extra fluids. This test looks at how the body responds when the legs are raised, which can indicate if more fluids would help improve heart function. The goal is to use this method to limit unnecessary fluid use, possibly leading to better recovery and shorter time on breathing machines.

To be eligible, participants should be adults aged 18 and older who are experiencing low blood pressure or are already receiving certain medications to help raise their blood pressure. They must also show signs of severe illness, such as confusion or low urine output, and be on a ventilator for breathing support. Those who join the trial will be monitored closely and may receive less fluid if the PLR test suggests it’s appropriate. This approach could help improve their overall condition while reducing the risks associated with too much fluid.

Gender

ALL

Eligibility criteria

• Pre-eligibility criteria:
• • Patients presenting on Intensive Care Unit (ICU) admission or later during their ICU stay with arterial hypotension (Mean arterial pressure \[MAP\]\<65mmHg or systolic arterial pressure \[SAP\]\< 90 mmHg at least two times over a 15-minute interval), regardless of the method used to measure blood pressure (invasive or non invasive),
• • Or patients already receiving continuous iv vasopressor therapy on ICU admission, regardless of the blood pressure level, will be considered as potential candidates for inclusion in the study, depending on his/her clinical evolution after 6 to 24 hours of care according to current guidelines for shock management.
• • In case arterial hypotension is present and/or the patient is already receiving continuous iv vasopressor at ICU admission, the date and time of admission will be considered as the time of shock onset (H0).
• • In case arterial hypotension occurs after ICU admission, the date and time of the first episode of hypotension will be considered as the time of shock onset (H0).
• Inclusion Criteria:
• * Patients will be eligible for inclusion if 6 hours after H0 (and before H24) all the following conditions are present:
• • Informed consent obtained (or emergency inclusion possible when legal representatives and patient's family are not present, as allowed by the Ethic Committee and by the French Law)
• • Persistence of arterial hypotension (as defined above) or continuous iv infusion of norepinephrine
• • Patient under invasive mechanical ventilation
• • At least one of the following conditions is present
• • Alteration of consciousness
• • Mottling skin
• • Cyanosis of the extremities despite SaO2\>90%
• • Oliguria defined as urine output below 0.5ml/kg of actual body weight over at least 1 hour
• • Arterial lactate \> 2 mmol/L
• • ScvO2 \< 70%
• • Central venous (internal jugular or subclavian) or femoral venous catheter in place
• • Arterial catheter in place
• Exclusion Criteria:
• • 1. Shock began more than 24 hours ago
• • 2. Age \< 18 yrs.
• • 3. Pregnancy
• • 4. Uncontrolled haemorrhage
• • 5. Intra-aortic balloon counterpulsation in place
• • 6. Patient under veno-arterial extracorporeal membrane oxygenation (V-A ECMO)
• • 7. Cardiogenic pulmonary oedema during the past 24 hours
• • 8. Patient equipped with a cardiac output monitoring device
• • 9. Brain death
• • 10. Moribund patient
• • 11. Traction of a lower limb
• • 12. Amputated lower limb above the ankle level
• • 13. Documented intra-abdominal hypertension
• • 13. Cardiac arrest motivating ICU admission or cardiac arrest since admission 14. Patient without social security number 15. Consent refusal