Effect of Early Administration of Albumin 20% Versus Crystalloid
ConditionSeptic Shock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorEgymedicalpedia
About this trial
Sepsis and septic shock are global health problems, leading to a high mortality rate. They are often associated with extremely low blood pressure and multiple organ dysfunctions, which are the main causes of death in critically ill patients. Fluid resuscitation is one of the most critical treatments for patients with sepsis and septic shock.
An early administration of an appropriate fluid to patients is considered the most effective way to increase blood pressure, improve tissue perfusion, and save their lives. Crystalloid fluids are a subset of intravenous solutions composed of mineral salts and other small, water-soluble molecules, including normal, isotonic or hypertonic saline, and various buffered solutions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Presence of septic shock that meets all the following Criteria: Clinically possible, probable, or microbiologically confirmed infection according to the definitions of the International-Sepsis- Forums (ISF), Despite adequate volume therapy, vasopressors are required to maintain mean arterial pressure (MAP) ≥ 65 mmHg for at least 1 hour, Serum lactate concentration > 2 mmol/l (18 mg/dl) despite adequate volume therapy.
Onset of septic shock less than 24 h prior to study inclusion.
Women of childbearing age: negative pregnancy test
Disqualifiers
Moribund conditions
End of life decisions
Previous participation to this trial or any other interventional clinical trial
Known hypersensitivity to albumin or any component of the trial drug
Trial design
Design model
Parallel
Treatments tested in this trial
Albumin Human
DrugTo investigate the effect of early administration of albumin in the ICU after onset of septic shock compared to volume replacement therapy without albumin on patient outcome.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Human Albumin GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recovery from shock
A reversal of hypotension (MAP) at the end of the first three hours of the resuscitation period.
Time frame
3 HoursSponsors and contacts
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Source ClinicalTrials.gov