Effect of Early Administration of Albumin 20% Versus Crystalloid

Septic Shock Clinical Trial

Official title:

Effect of Early Administration of Albumin 20% Versus Crystalloid During Resuscitation of Patient With Septic Shock: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370078
• Other study ID #: Ahmed Helal
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: November 15, 2025

Study information

• Verified date: April 2024
• Source: Egymedicalpedia
• Contact: Ahmed Abdelhamed Helal, MSC
• Phone: +201140415513
• Email: Ahmedel3oksh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: November 15, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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), (Calandra T, et al, 2005) 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.
• Age: = 18 years
• 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

Related Conditions & MeSH terms

• Septic Shock
• Shock, Septic

Intervention

Drug:
• Albumin Human
To 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.

Locations

Country	Name	City	State
Egypt	Assuit University hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery from shock	A reversal of hypotension (MAP) at the end of the first three hours of the resuscitation period.	3 Hours