Comparing early albumin administration to crystalloid fluids in septic shock treatment
Effect of Early Administration of Albumin 20% Versus Crystalloid During Resuscitation of Patient With Septic Shock: a Randomized Controlled Trial
This study is testing whether giving patients with septic shock a special protein solution called albumin works better than regular fluids to help raise their blood pressure and improve blood flow.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Egymedicalpedia Industry-sponsored |
| Locations | 1 site (Asyut) |
| Trial ID | NCT06370078 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of early administration of 20% albumin compared to crystalloid fluids in patients experiencing septic shock. The study aims to determine which type of fluid resuscitation is more effective in increasing blood pressure and improving tissue perfusion in critically ill patients. Participants must have septic shock with specific criteria, including low blood pressure and elevated lactate levels. The trial will assess the outcomes of fluid resuscitation methods to inform best practices in treating sepsis.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with septic shock who require vasopressors to maintain blood pressure despite adequate fluid therapy.
Not a fit: Patients with moribund conditions or those who have made end-of-life decisions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for septic shock, potentially reducing mortality rates.
How similar studies have performed: Previous studies have shown mixed results regarding fluid resuscitation strategies in septic shock, making this approach both relevant and necessary for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Asyut
- Assuit University hospitals — Asyut, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed Abdelhamed Helal, MSC
- Email: Ahmedel3oksh@gmail.com
- Phone: +201140415513
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.