eoPARDS - An efficacy and mechanism evaluation study of Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis.

Phase 1

Active, not recruiting

• Conditions: Septic shock.; MedDRA version: 16.0 Level: LLT Classification code 10028237 Term: Multiple organ failure System Organ Class: 100000004867; MedDRA version: 16.0 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2012-005159-18-GB
• Lead Sponsor: Imperial College, London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-01
• Study Completion: 2016-06-21
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 515

Inclusion Criteria

The target population is adult patients (=18 years) who require vasopressor support for the management of sepsis despite fluid resuscitation. Inclusion criteria will use the internationally-established consensus definitions of sepsis. In brief:

Fulfil 2/4 of the criteria of the systemic inflammatory response syndrome (SIRS) due to known or suspected infection within the previous 24 hours. The SIRS criteria are:
(1) fever (>38 C) or hypothermia (< 36 C),
(2) tachycardia (heart rate > 90 beats per minute),
(3) tachypnoea (respiratory rate > 20 breaths per minute or PaCO2 < 4.3 kPa) or need for mechanical ventilation,
(4) abnormal leukocyte count (> 12,000 cells/mm3, < 4000 cells/mm3, or > 10% immature [band] forms).

Hypotension, despite adequate intravenous fluid resuscitation, requiring treatment with a vasopressor infusion (e.g. noradrenaline / adrenaline / vasopressin analogue) for at least four hours and still having an ongoing vasopressor requirement at the time of randomisation.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 276

Exclusion Criteria

The exclusion criteria are as follows:

1. More than 24 hours since meeting all the inclusion criteria
2. End-stage renal failure at presentation (previously dialysis-dependent).
3. Severe hepatic impairment (Child-Pugh class C).
4. A history of Torsades de Pointes.
5. Significant mechanical obstructions affecting ventricular filling or outflow or both.
6. Treatment limitation decision in place (e.g. DNAR or not for ventilation/ dialysis).
7. Known or estimated weight >135kg.
8. Known to be pregnant.
9. Previous treatment with levosimendan within 30 days.
10. Known hypersensitivity to levosimendan or any of the excipients
111.Known to have received another investigational medicinal product within 30 days or currently in another interventional trial that might interact with the study drug.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified