Authorised Therapeutic exploratory (Phase II) Patients suffering from septic shock who require fluid resuscitation.

A Pilot, Randomized, Double-Blinded, Controlled Study of Hemodynamic and Acid Base Effects of 0.5M Sodium Lactate and 3% Saline Solutions in Septic Shock Patients

EU CTIS ID: 2024-517927-37-00

What this study is testing

The primary objective of a clinical trial is to compare the hemodynamic effects of an intravenous fluid bolus of 0.5M HSL (3ml/kg over 30 minutes) against 3% NaCl (3ml/kg over 30 minutes) in patients with septic shock.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Subjects will be eligible for the trial if they meet all of the following criteria: 1. Age criteria: 18 – 90 years 2. Septic shock - Sepsis 3 criteria : a) acute change in total SOFA score ≥ 2 due to infection b) use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmHg c) blood lactate level ≥ 2 mmol/L within last 24 hours 3. Likely need for fluid resuscitation a) poor peripheral perfusion as evidenced by 2 out of 4: i. peripheral cyanosis with delayed capillary refill ≥ 3 seconds ii. low urinary output (< 0.5 ml/kg/hour for at least 6 hours) iii. central venous O2 saturation < 70% iv. clouded sensorium/poor mentation b) dynamic assessment of preload responsiveness as evidenced by 1 out of 3: i. positive passive leg raising test ii. pulse pressure variation and / or stroke volume variation2, both > 12% iii. distensibility index of inferior vena caval diameter > 12% 4. Signed the relevant informed consent form (more in Chapter 10.1)

You likely can't join if

  • Subjects will not be eligible for the trial if they meet any of the following criteria: 1. Poor transthoracic echo windows 2. Actual body weight > 160 kg 3. Hypernatremia: [Na] > 150 mEq/L 4. Cardiac tamponade 5. Uncorrected severe valvular heart disease or life-threatening arrhythmia 6. Moribund patients likely to die before the study protocol is completed 7. Patients with absolute indication for immediate acute hemodialysis/hemofiltration (within 2 hrs) based on pH < 7.0, K > 7.0mmol/L 8. Severe liver dysfunction defined by total serum bilirubin > 120 umol/l 9. Pregnancy and lactation

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

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, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.