Effect of Early Administration of Albumin 20% Versus Crystalloid

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

Study Overview

• Status: Not yet recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Drug: Albumin Human

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Abdelhamed Helal, MSC; Phone Number: +201140415513; Email: Ahmedel3oksh@gmail.com
• Study Contact Backup: Name: Noha Yahia Mohamed, Lecturer; Phone Number: +201001890194; Email: Noha.hgagy@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Assuit University hospitals
    • Contact: Ahmed Abdelhamed Helal Mohamed, MSc; Phone Number: +201140415513; Email: Ahmedel3oksh@gmail.com
    • Contact: Amany Hassan Abdelwahab, Assist.Prof.; Phone Number: +201004610623; Email: Amanihassan1976@yahoo.com
    • Principal Investigator: Noha Yahia Mohamed, Lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Human Albumin Group; 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.	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.; Other Names: crystalloids
Active Comparator: Control Group; About 23 patients will be objected for resuscitation with 30 ml/kg crystalloid.	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.; Other Names: crystalloids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery from shock	A reversal of hypotension (MAP) at the end of the first three hours of the resuscitation period.	3 Hours

Collaborators and Investigators

• Sponsor: Egymedicalpedia
• Investigators: Study Chair: Mohamed Ahmed Mohamed, Professor, ICU department , Faculty of Medicine, Assuit University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 15, 2025

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Shock, Septic
• Other Study ID Numbers: Ahmed Helal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No