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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004384-29-GB

Enrollment

Registered

2005-02-15

Start date

2005-05-23

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Interventions

Trade Name: SIMDAX Product Name: Levosimendan (SIMDAX) Product Code: n/a Pharmaceutical Form: Concentrate for solution for infusion INN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1). Presence of septic shock (as given by) Septic shock is characterised by: · Hypotension: Mean arterial pressure 38C). ii). Heart rate >90 bpm. iii). Respiratory rate >20 bpm iv). Leucopenia (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 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

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.

Design outcomes

Primary

Measure	Time frame
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.; Primary end point(s): Endpoints: The primary endpoint will be an improvement in intramucosal gut pH (pHi) Secondary endpoints: · Decreased Lactic acidosis. · Improvement in urine output / renal function. · Changes from baseline in cardiovascular parameters (in particular marked hypotension or other poorly tolerated side effects). · Use of concomitant inotropic support. · Length of survival in critical care. · Length of hospital survival. · 6 months mortality.	—

Measure

Time frame

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.; Primary end point(s): Endpoints: The primary endpoint will be an improvement in intramucosal gut pH (pHi) Secondary endpoints: · Decreased Lactic acidosis. · Improvement in urine output / renal function. · Changes from baseline in cardiovascular parameters (in particular marked hypotension or other poorly tolerated side effects). · Use of concomitant inotropic support. · Length of survival in critical care. · Length of hospital survival. · 6 months mortality.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026