Vasopressin vs Noradrenaline as Initial therapy in Septic Shock

Phase 1

• Conditions: Septic Shock; MedDRA version: 17.0 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-005363-24-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-09
• Study Completion: 2015-06-03
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 409

Inclusion Criteria

The target population is adult patients who require vasopressors for the management of sepsis despite fluid resuscitation.

All patients who are clinically judged to have septic shock will be screened against the specific inclusion and exclusion criteria and these criteria will be recorded in the eCRF.

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.

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 212
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

•Patient has received a continuous infusion of vasopressors previously during this ICU admission (other than vasopressors used as emergency treatment [for less than six hours] to stabilise the patient during this episode). Vasopressors include noradrenaline, adrenaline, vasopressin, dopamine, metaraminol, phenylephrine, and (intermittent) terlipressin.

•Regular systemic corticosteroid therapy within the previous three months (this does not include inhaled steroid therapy).

•Known adrenal dysfunction / insufficiency.

•End-stage renal failure (i.e. requiring long term dialysis)

•Physician and team are not committed to full active care.

•Patient is known to be pregnant.

•Patient has known acute mesenteric ischemia.

•Patient is known to have Raynaud's phenomenon, systemic sclerosis or other vasospastic diseases.

•Patient has been enrolled in another clinical trial of an investigational medicinal product within 30 days or is enrolled in another investigational study that might interact with the study drugs.

•Patient has a history of anaphylaxis to any study drug.

Study & Design

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