Effect of Early Administration of Albumin 20% Versus Crystalloid

Egymedicalpedia

Status: Enrolling

Conditions: Septic Shock

Treatments: Drug: Albumin Human

Study type: Interventional

Funder types: Industry

Identifiers

NCT06370078

Ahmed Helal

Details and patient eligibility

About

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.

Full description

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.

Colloid solutions are composed of various amounts of substances, for instance, albumin, hydroxyethyl starch, dextran, and gelatine. Although the current international guidelines from the Surviving Sepsis Campaign recommend crystalloids to perform the initial resuscitation, and the replacement with albumin on patients who require substantial amounts of crystalloids, the choice of the best type of resuscitation fluids is still under debate.

Albumin, in addition to its oncotic functions, has a variety of other properties, including binding and transport of various endogenous molecules, anti-inflammatory and anti-oxidative effects, and modulation of nitric oxide metabolism.These properties are particularly relevant in critically ill patients, especially in patients with sepsis.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Clinical conditions, where albumin administration may be unfavourable
• Breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Human Albumin Group

Experimental group

Description:

About 23 patients will be objected for resuscitation with 60 gm (300 ml) human albumin 20% (HA 20%) over 2-3 hours combined usual practice with 30 ml/kg crystalloid.

Treatment:

Drug: Albumin Human

Control Group

Active Comparator group

Description:

About 23 patients will be objected for resuscitation with 30 ml/kg crystalloid.

Treatment:

Drug: Albumin Human