Effect of Early Administration of Albumin 20% Versus Crystalloid
NCT ID: NCT06370078
Last Updated: 2024-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
46 participants
INTERVENTIONAL
2024-06-01
2024-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
Control Group
About 23 patients will be objected for resuscitation with 30 ml/kg crystalloid.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Onset of septic shock less than 24 h prior to study inclusion.
* Women of childbearing age: negative pregnancy test
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Egymedicalpedia
INDUSTRY
Responsible Party
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Principal Investigators
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Mohamed Ahmed Mohamed, Professor
Role: STUDY_CHAIR
ICU department , Faculty of Medicine, Assuit University
Locations
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Assuit University hospitals
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Ahmed Helal
Identifier Type: -
Identifier Source: org_study_id
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