Volume Kinetics of Fluid Resuscitation in Early Sepsis (NCT06499701) | Clinical Trial Compass
RecruitingNot Applicable
Volume Kinetics of Fluid Resuscitation in Early Sepsis
Romania15 participantsStarted 2024-06-19
Plain-language summary
The recommended volume resuscitation for patients with early sepsis-induced hypoperfusion is at least 30 ml/kg of crystalloid administered within the first three hours. However, this standardized approach does not account for individual patient variability and lacks personalization. Additionally, the effects of administering 30 ml/kg on intercompartmental fluid shifts between the plasma and interstitial compartments remain unclear. This study aims to describe the volume kinetics of administering 30 ml/kg of Ringer's Lactate in patients with early sepsis-induced hypoperfusion within the first three hours.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
A diagnosis of sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to the administration of adequate volume resuscitation:
* hypotension requiring norepinephrine to maintain a mean arterial blood pressure (MAP) either predefined by the clinician or at 65 mm Hg or higher and/or
* a serum lactate level \>2 mmol/L (18mg/dL) and/or
* acute oliguria defined as urine output \<0.5mL/kg/hr and/or
* mottled skin and/or
* capillary refill time \> 3 seconds.
Exclusion Criteria:
* Administration of at least 1 L of IV fluid in the last 6 hours prior to screening. All crystalloids, colloids and blood products that the patient has received are counted.
* Known pregnancy.
* Competing causes of lactic acidosis including: seizures within 3 hours of enrollment, use of linezolid or metformin or anti-retrovirals at the time of enrollment, carbon monoxide or cyanide poisoning, highly suspected or known ischemic bowel, and known mitochondrial disorders.
* End-stage renal disease that requires chronic dialysis.
* Concurrent haemorrhagic or obstructive shock.
* Increased risk of fluid intolerance:
* Echocardiographic evidence of moderate or severe left ventricular systolic dysfunction.
* Echocardiographic evidence of moderate or severe right ventricular systolic dysfunction.
* Hypoxemia index \< 200 mmHg or sonographic evidence of bilateral B or C profile.
* Abdominal compartment syndrome.
* Post-cardiac arrest.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma Volume
Timeframe: 180 minutes after the start of the Ringer's Lactate infusion
Trial details
NCT IDNCT06499701
SponsorInstitutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu