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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fakultni Nemocnice Plzen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Trial duration

24 Nov 2024 → ongoing

Decision date (initial)

2024-11-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517927-37-00

EudraCT number

2022-003846-10

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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.

Secondary objectives 1

1. The secondary objective is to assess acid base 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.

Conditions and MedDRA coding

Patients suffering from septic shock who require fluid resuscitation.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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)

Exclusion criteria 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in cardiac stroke work (SW = SV x MAP) assessed by means of transthoracic echocardiography (SV) and a fluid filled arterial pressure transducer system (MAP) measured at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus (0.5M HSL or 3% NaCl). Monitored parameters:  SV (mL; start of infusion, 30 min and 60 min after start of infusion)  MAP (mmHg; start of infusion, 30 min and 60 min after start of infusion)

Secondary endpoints 1

1. Comparison of laboratory values of arterial blood gases and electrolytes between study groups

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fakultni Nemocnice Plzen

Sponsor organisation

Fakultni Nemocnice Plzen

Address

Alej Svobody 923/80

City

Plzen 23

Postcode

323 00

Country

Czechia

Scientific contact point

Organisation

Fakultni Nemocnice Plzen

Contact name

Kříž Miroslav MD

Public contact point

Organisation

Fakultni Nemocnice Plzen

Contact name

Kříž Miroslav MD

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications