Double blind randomised controlled trial of Levosimendan versus Dopexamine in septic shock

Phase 1

• Conditions: Septic Shock

• Registration Number: EUCTR2004-004384-29-GB
• Lead Sponsor: Dr GED DEMPSEY, University Hospital Aintree

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-15
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1). Presence of septic shock (as given by)

Septic shock is characterised by:

·Hypotension:
Mean arterial pressure <60mmHg or the requirement for inotropic or vasopressor drugs to maintain a pressure above this, despite adequate volume resuscitation.

·Perfusion abnormalities:
Lactic acidosis, oliguria and mental impairment associated with sepsis.

·Systemic Inflammatory Response Syndrome (SIRS) as a result of a known or presumed bacteraemia.

SIRS is defined as two or more of following:

i).Hypothermia (<36C) or hyperthermia (>38C).

ii).Heart rate >90 bpm.

iii).Respiratory rate >20 bpm

iv).Leucopenia (<4000/mm3) or leucocytosis (>12,000/mm3).

2). When the use of Dopexamine added to the inotropic regimen may be considered to be beneficial. This will be due to the presence of one or more of the following.

i).Renal dysfunction / oliguria. (Urine output of <0.5 ml/Kg/hr for 2 consecutive hours, in adequately resuscitated patients).

ii).Lactic acidosis.(pH<7.35 with lactate>2mmol/l).

iii).Increasing intramucosal gastric acidosis. ( Decreased pHi ).

Such that an agent considered to preserve splanchnic perfusion may be deemed necessary.

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

Exclusion Criteria

Exclusions

·Age < 18 years of age
·Involvement in another randomised controlled trial within 3 months.
·Pacemaker
·Child bearing potential.
·Know hypertrophic obstructive cardiomyopathy
·Known stenotic valvular pathology
·Patient not expected to survive more than 24 hrs.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the role of Levosimendan in preserving blood flow to the splanchnic circulation in septic shock as compared to dopexamine.;Secondary Objective: To establish whether there is an improvement in haemodynamic and cardiac parameters.;<br> Primary end point(s): Endpoints:<br><br><br> The primary endpoint will be an improvement in intramucosal gut pH (pHi)<br><br> Secondary endpoints:<br><br> ·Decreased Lactic acidosis.<br> ·Improvement in urine output / renal function.<br> ·Changes from baseline in cardiovascular parameters (in particular marked hypotension or other poorly tolerated side effects).<br> ·Use of concomitant inotropic support.<br> ·Length of survival in critical care.<br> ·Length of hospital survival.<br> ·6 months mortality.<br><br><br>