Critical IllnessPhase 3ALBUSNCT07212582

Human Albumin for Resuscitation in Surgical Septic Shock: A Randomized Controlled Trial (ALBUS Study)

A Phase 3 study testing Human Albumin 20% Solution in people with Critical Illness and Septic Shock, run by Mahidol University at 1 site in Thailand.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This study will test whether giving human albumin to keep the blood albumin level above 3.5 g/dL, in addition to standard care, improves survival in patients with surgical septic shock. Septic shock is a life-threatening complication of infection that often requires urgent surgery and intensive care. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Critical Illness, Septic Shock
What is being tested?: Human Albumin 20% Solution
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 304 participants
Where: 1 siteThailand
Study dates: 1 Dec 2025to 31 Dec 2030
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients (≥18 years) admitted to the surgical intensive care unit (SICU).
Diagnosis or suspicion of surgical infection requiring surgery or surgical intervention within 48 hours of ICU admission.
Septic shock, defined as:
Mean arterial pressure <65 mmHg after adequate fluid resuscitation or requirement for vasopressors to maintain mean arterial pressure (MAP) ≥65 mmHg for at least 1 hour, and
Evidence of organ dysfunction (Sequential Organ Failure Assessment (SOFA) score increase ≥2) or signs of tissue hypoperfusion (serum lactate >2 mmol/L, oliguria <0.5 mL/kg/h >2 h, or clinical evidence of poor peripheral perfusion).

Who cannot join

Refusal of consent or do-not-resuscitate (DNR) status.
More than 24 hours since meeting inclusion criteria.
Contraindication to albumin infusion or history of severe allergic reaction to albumin.
Conditions where albumin infusion is already indicated (e.g., large-volume paracentesis >5 L, hepatorenal syndrome, spontaneous bacterial peritonitis, plasmapheresis, cirrhosis, nephrotic syndrome, protein-losing enteropathy, severe burns, post-cardiac or thoracic surgery).
Evidence of fluid overload or pulmonary edema (bilateral crepitations, chest infiltrates consistent with pulmonary edema, Central Venous Pressure >15 mmHg, Pulmonary Artery Occlusion Pressure [PAOP] >18 mmHg, or N-terminal pro-B-type Natriuretic Peptide [NT-proBNP] >900 pg/mL)
End-stage renal disease or receiving chronic renal replacement therapy.
Pregnancy or breastfeeding.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nuanprae Kitisin, MD contact

+66896767706

nuanprae.kit@mahidol.ac.th

Thailand1 site

Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Bangkoknoi, 10700
Nuanprae Kitisin, +66896767706, nuanprae.kit@mahidol.ac.th
Nattachai Hemtanon, MD, +66656351622, nattachaihem@gmail.com

Other trials in Thailand

About this study

Official title: A Study of the Additional Human Albumin During Resuscitation in Patients With Surgical Septic Shock in Surgical Intensive Care Units: A Randomized Controlled Trial (The ALBumin Use in Surgical Septic Shock, ALBUS Study)

Human albumin is a natural protein in the blood that helps maintain fluid balance and has anti-inflammatory effects. Previous studies suggest that low albumin levels are linked with worse outcomes in septic patients, and that albumin infusion might improve recovery, but results are mixed and evidence in surgical septic shock patients is lacking.

In this randomized controlled trial, adult patients with surgical septic shock admitted to the surgical intensive care unit will be randomly assigned to receive either standard care alone or standard care plus 20% human albumin solution for up to 3 days. The main outcome is survival at 28 days. Secondary outcomes include length of ICU and hospital stay, need for dialysis, ventilator-free days, vasopressor-free days, fluid balance, gastrointestinal recovery, and adverse reactions.

The results of this study will help determine whether targeted albumin replacement is beneficial in critically ill surgical patients with septic shock and could guide future fluid resuscitation strategies.

Read the detailed description

This is a single-center, randomized, open-label, controlled trial designed to evaluate the effect of targeted albumin replacement in adult patients with surgical septic shock. The study will be conducted in the Surgical Intensive Care Unit at Siriraj Hospital, Bangkok, Thailand.

Eligible patients are those aged 18 years or older admitted with surgical septic shock, defined as suspected or proven surgical infection requiring an operation or surgical intervention within 48 hours, and persisting shock despite adequate initial fluid resuscitation. After informed consent, participants will be randomized in a 1:1 ratio, using block randomization, to one of two groups:

Control group: Standard sepsis management according to international guidelines, including source control, broad-spectrum antibiotics, intravenous crystalloids, vasopressors, and other adjunctive therapies as required.

Intervention group: Standard care plus intravenous 20% human albumin solution, given for up to 72 hours, with dosing guided by serum albumin levels to maintain concentrations above 3.5 g/dL.

The primary endpoint is 28-day all-cause mortality. Secondary endpoints include length of ICU and hospital stay, ventilator-free days, vasopressor-free days, 7-day cumulative fluid balance, acute kidney injury requiring renal replacement therapy, recovery of gastrointestinal function, and adverse reactions.

The planned sample size is 304 patients (152 per arm), which provides 80% power to detect a relative risk reduction of 40% in 28-day mortality (from 35% to 20%) with two-sided alpha of 0.05, accounting for 10% attrition.

Data will be analyzed primarily on an intention-to-treat basis. Interim analysis is planned after 50% enrollment to assess safety and efficacy. Both frequentist and Bayesian approaches will be applied, including logistic regression to adjust for baseline imbalances if needed.

This trial will provide evidence on whether maintaining serum albumin above 3.5 g/dL with human albumin infusion improves survival and clinical outcomes in critically ill patients with surgical septic shock.

Conditions: Critical Illness, Septic Shock
Being tested: Human Albumin 20% Solution, Standard Care (in control arm)
Keywords: human albumin, fluid resuscitation, colloids, Surgical Intensive Care Unit (SICU), surgical septic shock, Randomized Controlled Trial
Medical subject headings: Critical Illness, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Human Albumin 20% SolutionDrug
Intravenous 20% human albumin solution (50 mL per vial). In the experimental arm, patients receive 50 mL over 2 hours on admission, followed by additional doses for up to 72 hours, titrated to maintain serum albumin >3.5 g/dL. If albumin is 2.5-3.4 g/dL, 1 vial every 12 hours is given; if <2.5 g/dL, 1 vial every 6 hours is given. Infusion is withheld if there is fluid overload, pulmonary edema, or severe hypernatremia.
Standard Care (in control arm)Other
Patients in this group will receive standard sepsis management according to international guidelines. This includes source control, intravenous broad-spectrum antibiotics, balanced crystalloids, vasopressors, and adjunctive therapies (e.g., corticosteroids, thiamine, ventilatory and renal support) as clinically indicated. Albumin may be given if separate indications arise (e.g., perioperative use, severe hypoalbuminemia <2.5 g/dL with capillary leakage), at the discretion of the treating physician.

Study groups in NCT07212582
Study group	Role	What they receive
Standard Care	Active comparator	Patients in this group will receive standard sepsis management according to international guidelines. This includes source control, intravenous broad-spectrum antibiotics, balanced crystalloids, vasopressors, and adjunctive therapies (e.g., corticosteroids, thiamine, ventilatory and renal support) as clinically indicated. Albumin may be given if separate indications arise (e.g., perioperative use, severe hypoalbuminemia <2.5 g/dL with capillary leakage), at the discretion of the treating physician. Receives: Other: Standard Care (in control arm)
Standard Care Plus Albumin	Experimental	Patients in this group will receive standard sepsis management as above, plus intravenous 20% human albumin solution. On admission, 50 mL of 20% albumin will be infused over 2 hours, followed by additional doses for up to 72 hours, titrated according to daily serum albumin levels. The target is to maintain serum albumin >3.5 g/dL: 1 vial every 12 hours if 2.5-3.4 g/dL, or every 6 hours if <2.5 g/dL. Infusion will be withheld in the presence of fluid overload, pulmonary edema, or severe hypernatremia. Receives: Drug: Human Albumin 20% Solution; Other: Standard Care (in control arm)

What is being measured

The primary outcome is the main question the study is designed to answer.

28-Day All-Cause Mortality
Mortality from any cause within 28 days of ICU admission, assessed by review of hospital records and/or telephone follow-up if the patient is discharged before Day 28.
Measured: 28 days after randomization

Secondary outcomes (6)

ICU Length of Stay
Number of days from ICU admission to ICU discharge. For participants who die in the ICU, length of stay will be recorded up to the date of death.
Measured: From ICU admission until ICU discharge or death in the ICU, assessed for up to 90 days.
Hospital Length of Stay
Number of days from hospital admission to hospital discharge. For participants who die in the hospital, length of stay will be recorded up to the date of death.
Measured: From hospital admission until hospital discharge or in-hospital death, assessed for up to 90 days.
Vasopressor-Free Days
Number of days alive and without vasopressor therapy during the first 28 days. Patients who die before Day 28 will be assigned zero vasopressor-free days.
Measured: 28 days after randomization
7-Day Cumulative Fluid Balance
Net fluid balance (total fluid input minus total output) recorded daily and summed across the first 7 days of ICU stay.
Measured: First 7 days after randomization
Acute Kidney Injury Requiring Renal Replacement Therapy
Incidence of renal replacement therapy initiation for acute kidney injury, determined from ICU and hospital records.
Measured: Up to 28 days after randomization
Adverse Reactions
Incidence of adverse reactions related to albumin infusion, including allergic or anaphylactic reactions, pulmonary edema, or electrolyte disturbances.
Measured: Up to 28 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202531 Dec 2030

First posted8 Oct 2025
Study start1 Dec 2025 (estimated)
Primary completion31 Dec 2029 (estimated)
Study completion31 Dec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Critical IllnessStudies of the same condition, open and under way.
More trials run by Mahidol UniversityThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Eligible patients will be randomized in a 1:1 ratio to receive either standard care alone or standard care plus intravenous 20% human albumin solution for up to 72 hours. Randomization will be performed using block randomization with a block size of 4.
Masking: None (open label)
Enrolment: 304 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07212582
Sponsor's protocol ID: ALBUS_SIRIRAJ
Acronym: ALBUS
Status last verified: Nov 2025
First submitted: 1 Oct 2025
Last updated: 19 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data (IPD) will not be shared because of institutional policies at Siriraj Hospital that restrict the transfer of identifiable patient-level data outside the institution. Only aggregate, de-identified data will be reported in publications and presentations. Researchers interested in collaboration may contact the study investigators to discuss potential data analyses consistent with local regulations.

Interested in taking part?

Nuanprae Kitisin, MD

+66896767706

nuanprae.kit@mahidol.ac.th

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of the Additional Human Albumin During Resuscitation in Patients With Surgical Septic Shock in Surgical Intensive Care Units: A Randomized Controlled Trial (The ALBumin Use in Surgical Septic Shock, ALBUS Study)
ClinicalTrials.gov ID: NCT07212582
Acronym / sponsor ID: ALBUS / ALBUS_SIRIRAJ
Conditions: Critical Illness, Septic Shock
Keywords: human albumin, fluid resuscitation, colloids, Surgical Intensive Care Unit (SICU), surgical septic shock, Randomized Controlled Trial
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 304 participants (estimated)
Lead sponsor: Mahidol UniversityUniversity, hospital or other
Study start: 1 Dec 2025 (estimated)
Primary completion: 31 Dec 2029 (estimated)
Study completion: 31 Dec 2030 (estimated)
First posted: 8 Oct 2025 (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.

Detailed description

Intervention group: Standard care plus intravenous 20% human albumin solution, given for up to 72 hours, with dosing guided by serum albumin levels to maintain concentrations above 3.5 g/dL.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Eligible patients will be randomized in a 1:1 ratio to receive either standard care alone or standard care plus intravenous 20% human albumin solution for up to 72 hours. Randomization will be performed using block randomization with a block size of 4.

Arm	Type	Receives
Standard Care	Active comparator	Other: Standard Care (in control arm)Patients in this group will receive standard sepsis management according to international guidelines. This includes source control, intravenous broad-spectrum antibiotics, balanced crystalloids, vasopressors, and adjunctive therapies (e.g., corticosteroids, thiamine, ventilatory and renal support) as clinically indicated. Albumin may be given if separate indications arise (e.g., perioperative use, severe hypoalbuminemia <2.5 g/dL with capillary leakage), at the discretion of the treating physician.
Standard Care Plus Albumin	Experimental	Drug: Human Albumin 20% Solution, Other: Standard Care (in control arm)Patients in this group will receive standard sepsis management as above, plus intravenous 20% human albumin solution. On admission, 50 mL of 20% albumin will be infused over 2 hours, followed by additional doses for up to 72 hours, titrated according to daily serum albumin levels. The target is to maintain serum albumin >3.5 g/dL: 1 vial every 12 hours if 2.5-3.4 g/dL, or every 6 hours if <2.5 g/dL. Infusion will be withheld in the presence of fluid overload, pulmonary edema, or severe hypernatremia.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adult patients (≥18 years) admitted to the surgical intensive care unit (SICU).
Diagnosis or suspicion of surgical infection requiring surgery or surgical intervention within 48 hours of ICU admission.
Septic shock, defined as:
Mean arterial pressure <65 mmHg after adequate fluid resuscitation or requirement for vasopressors to maintain mean arterial pressure (MAP) ≥65 mmHg for at least 1 hour, and
Evidence of organ dysfunction (Sequential Organ Failure Assessment (SOFA) score increase ≥2) or signs of tissue hypoperfusion (serum lactate >2 mmol/L, oliguria <0.5 mL/kg/h >2 h, or clinical evidence of poor peripheral perfusion).

Key exclusion criteria (7 listed)

Refusal of consent or do-not-resuscitate (DNR) status.
More than 24 hours since meeting inclusion criteria.
Contraindication to albumin infusion or history of severe allergic reaction to albumin.
Conditions where albumin infusion is already indicated (e.g., large-volume paracentesis >5 L, hepatorenal syndrome, spontaneous bacterial peritonitis, plasmapheresis, cirrhosis, nephrotic syndrome, protein-losing enteropathy, severe burns, post-cardiac or thoracic surgery).
Evidence of fluid overload or pulmonary edema (bilateral crepitations, chest infiltrates consistent with pulmonary edema, Central Venous Pressure >15 mmHg, Pulmonary Artery Occlusion Pressure [PAOP] >18 mmHg, or N-terminal pro-B-type Natriuretic Peptide [NT-proBNP] >900 pg/mL)

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
Human Albumin 20% SolutionIntravenous 20% human albumin solution (50 mL per vial). In the experimental arm, patients receive 50 mL over 2 hours on admission, followed by additional doses for up to 72 hours, titrated to maintain serum albumin >3.5 g/dL. If albumin is 2.5-3.4 g/dL, 1 vial every 12 hours is given; if <2.5 g/dL, 1 vial every 6 hours is given. Infusion is withheld if there is fluid overload, pulmonary edema, or severe hypernatremia.	Drug	Standard Care Plus Albumin
Standard Care (in control arm)Patients in this group will receive standard sepsis management according to international guidelines. This includes source control, intravenous broad-spectrum antibiotics, balanced crystalloids, vasopressors, and adjunctive therapies (e.g., corticosteroids, thiamine, ventilatory and renal support) as clinically indicated. Albumin may be given if separate indications arise (e.g., perioperative use, severe hypoalbuminemia <2.5 g/dL with capillary leakage), at the discretion of the treating physician.	Other	Standard Care, Standard Care Plus Albumin

Primary outcome

28-Day All-Cause Mortality
Time frame: 28 days after randomization
Mortality from any cause within 28 days of ICU admission, assessed by review of hospital records and/or telephone follow-up if the patient is discharged before Day 28.

6 secondary outcomes

ICU Length of Stay
Time frame: From ICU admission until ICU discharge or death in the ICU, assessed for up to 90 days.
Hospital Length of Stay
Time frame: From hospital admission until hospital discharge or in-hospital death, assessed for up to 90 days.
Vasopressor-Free Days
Time frame: 28 days after randomization
7-Day Cumulative Fluid Balance
Time frame: First 7 days after randomization
Acute Kidney Injury Requiring Renal Replacement Therapy
Time frame: Up to 28 days after randomization
Adverse Reactions
Time frame: Up to 28 days after randomization

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because of institutional policies at Siriraj Hospital that restrict the transfer of identifiable patient-level data outside the institution. Only aggregate, de-identified data will be reported in publications and presentations. Researchers interested in collaboration may contact the study investigators to discuss potential data analyses consistent with local regulations.

Related trials for Critical Illness

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Recruiting
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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.

Nuanprae Kitisin, MD contact

+66896767706

nuanprae.kit@mahidol.ac.th

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Human Albumin 20% Solution in people with Critical Illness and Septic Shock, run by Mahidol University at 1 site in Thailand.

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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 19 Nov 2025. 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 Thailand. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nuanprae Kitisin, MD (+66896767706, nuanprae.kit@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28-Day All-Cause Mortality (time frame: 28 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07212582.

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 19 Nov 2025.