A large 2-by-2 factorial randomized clinical trial testing the efficacy of albumin and the low-chloride balanced crystalloid solutions (either Ringer Lactate, Ringer Acetate, or Crystalsol – BAL) in septic shock.

Phase 1

• Conditions: Septic shock; MedDRA version: 20.0 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-001582-16-IT
• Lead Sponsor: FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients will be enrolled if they meet the two following criteria:
1) Presence of an infection (known or suspected) in at least one site:
a) Lung
b) Abdomen
c) Urinary tract
d) Others (blood, skin and soft tissues, central nervous
system, bones and joints, cardiac system,
reproductive organs)
2) Presence of a severe and acute, sepsis-related
cardiovascular failure, requiring vasopressor to maintain mean arterial pressure >= 65 mmHg, despite adequate volume resuscitation
a) Cardiovascular SOFA score > 2 (3 or 4)
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 751
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 501

Exclusion Criteria

1)Age < 18 years
2)Moribund state
3)Known or suspected adverse reaction to albumin administration
4)Severe sepsis or septic shock in patients with traumatic brain injury or a clinically active cerebral lesion (known or suspected)
5) Severe congestive heart failure (NYHA III and IV classes)
6) Clinical situations in which the use of albumin is known or supposed to be
clinically effective (hepatic cirrhosis with ascites, malabsorption syndrome or
protein-losing enteropathy, nephrotic syndrome, burns)
7) More than 24 hours after the onset of septic shock
8) Religious objection to the administration of human blood products
9) Presence of chronic end-stage renal disease
10)Severe hyperkalemia
11)Enrollment in other experimental studies

Study & Design

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