An efficacy and mechanism evaluation study of levosimendan for the prevention of acute organ dysfunction in sepsis

Not Applicable

Completed

• Conditions: Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Critical Care; Signs and Symptoms; Septic shock

• Registration Number: ISRCTN12776039
• Lead Sponsor: Imperial College of Science, Technology and Medicine (UK)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24894386 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27705084 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30431749

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-19
• Study Completion: 2016-10-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 516

Inclusion Criteria

1. The target population includes adult patients (=18 years) who require vasopressor support for the management of sepsis despite fluid resuscitation
2. Inclusion criteria will use the internationally-established consensus definitions of sepsis. In brief, fulfil 2 out of 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:
2.1. Fever (>38 C) or hypothermia (< 36 C)
2.2. Tachycardia (heart rate > 90 beats per minute)
2.3. Tachypnoea (respiratory rate > 20 breaths per minute or PaCO2 < 4.3 kPa) or need for mechanical ventilation
2.4. Abnormal leukocyte count [> 12,000 cells/mm3, < 4000 cells/mm3, or > 10% immature (band) forms]
3. 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.

Target Gender: Male & Female

Exclusion Criteria

The exclusion criteria are as follows:
1. More than 24 hours since meeting all the inclusion criteria
2. Endstage 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. Do not attempt resuscitation (DNAR) or not for ventilation/dialysis]
7. Known or estimated weight of more than135kg
8. Known to be pregnant
9. Previous treatment with levosimendan within 30 days
10. Known hypersensitivity to levosimendan or any of the excipients
11. 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
• Study Design: Not specified