Effect of Early Administration of Albumin 20% Versus Crystalloid

NCT06370078 | Recruiting DMC

• 1 other identifier: Ahmed Helal
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Recovery from shock

  A reversal of hypotension (MAP) at the end of the first three hours of the resuscitation period.

  3 Hours

Study Arms (2)

Human Albumin Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Drug: Albumin Human

Interventions

Albumin Human DRUG

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.

Also known as: crystalloids

Control Group; Human Albumin Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Women of childbearing age: negative pregnancy test

You may not qualify if:

• 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

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Assuit University hospitals

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Interventions

Serum Albumin, Human; Crystalloid Solutions

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mohamed Ahmed Mohamed, Professor

  ICU department , Faculty of Medicine, Assuit University

  STUDY CHAIR

Central Study Contacts

Ahmed Abdelhamed Helal, MSC

CONTACT

+201140415513; Ahmedel3oksh@gmail.com

Noha Yahia Mohamed, Lecturer

CONTACT

+201001890194; Noha.hgagy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: June 1, 2024
• Primary Completion: November 20, 2024
• Study Completion: November 30, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

EG (1)