Septic ShockNCT06370078
Effect of Early Administration of Albumin 20% Versus Crystalloid
A study testing Albumin Human in people with Septic Shock, run by Egymedicalpedia at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Albumin Human
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assuit University hospitals
Asyut
Ahmed Abdelhamed Helal Mohamed, MSc, +201140415513, Ahmedel3oksh@gmail.com
Amany Hassan Abdelwahab, Assist.Prof., +201004610623, Amanihassan1976@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Septic Shock
- Being tested
- Albumin Human
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin HumanDrug
Also called crystalloids
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Albumin Human |
| Control Group | Active comparator | About 23 patients will be objected for resuscitation with 30 ml/kg crystalloid. Receives: Drug: Albumin Human |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery from shock
A reversal of hypotension (MAP) at the end of the first three hours of the resuscitation period.
Measured: 3 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jun 2024
- Primary completion20 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohamed Ahmed Mohamed, Professor, Study chair, ICU department , Faculty of Medicine, Assuit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370078
- Sponsor's protocol ID
- Ahmed Helal
- Status last verified
- Jun 2024
- First submitted
- 12 Apr 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Administration of Albumin 20% Versus Crystalloid During Resuscitation of Patient With Septic Shock: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06370078
- Acronym / sponsor ID
- Ahmed Helal
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Albumin Group | Experimental | Drug: Albumin HumanAbout 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. |
| Control Group | Active comparator | Drug: Albumin HumanAbout 23 patients will be objected for resuscitation with 30 ml/kg crystalloid. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin HumanAlso: crystalloidsTo 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. | Drug | Control Group, Human Albumin Group |
Primary outcome
Recovery from shock
Time frame: 3 Hours
A reversal of hypotension (MAP) at the end of the first three hours of the resuscitation period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Ahmed Mohamed, Professor study chair
ICU department , Faculty of Medicine, Assuit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albumin Human in people with Septic Shock, run by Egymedicalpedia at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abdelhamed Helal, MSC (+201140415513, Ahmedel3oksh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery from shock (time frame: 3 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.