Acute Respiratory Distress SyndromeALB-SARDSNCT07857928
Effect of Albumin Therapy in Mechanically Ventilated Patients With Sepsis-Associated ARDS
An observational study of Acute Respiratory Distress Syndrome and Sepsis, run by The Second Affiliated Hospital of Hainan Medical University at 1 site in China.
Trial summary
Sepsis-associated acute respiratory distress syndrome (ARDS) is a severe condition where severe infection causes fluid accumulation in the lungs, often requiring invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Sepsis, Hypoalbuminemia
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2026to 31 Dec 2027
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises critically ill adult patients admitted to the intensive care units (ICUs) at the Second Affiliated Hospital of Hainan Medical University. Eligible participants are those diagnosed with sepsis-associated acute respiratory distress syndrome (ARDS) who require invasive mechanical ventilation and have confirmed hypoalbuminemia (serum albumin ≤ 30 g/L). The prospective cohort is identified consecutively from active ICU admissions, while the historical control cohort is identified retrospectively from electronic medical records of patients admitted prior to the routine implementation of the targeted albumin protocol.
Who may be able to join
- Aged 18 years or older.
- Clinical diagnosis conforming to the Sepsis-3 consensus criteria.
- Diagnosis of acute respiratory distress syndrome (ARDS) fulfilling the European Society of Intensive Care Medicine (ESICM) criteria (mild, moderate, or severe).
- Receiving invasive mechanical ventilation, with an intubation duration ≤ 48 hours at study enrollment.
- First admission to the intensive care unit (ICU) ≤ 24 hours prior to enrollment.
- Baseline serum albumin concentration ≤ 30 g/L measured at hospital or ICU admission.
- Anticipated ICU stay of > 48 hours.
Who cannot join
- Female patients who are pregnant or lactating.
- Severe burn injury or currently receiving extracorporeal membrane oxygenation (ECMO) support.
- Perioperative period of liver transplantation or decompensated liver cirrhosis (Child-Pugh class C).
- End-stage malignancy or an estimated clinical life expectancy < 3 months.
- Signed Do-Not-Resuscitate (DNR) order, agreement to withhold/withdraw active life-sustaining therapy, or moribund state expected to result in death within 24 hours.
- Known history of severe hypersensitivity or anaphylactic shock to human serum albumin preparations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570003
Fengyun Wang, MD/PhD, 8619389918115, dr-w@qq.com
About this study
Official title: A Prospective Observational Study With Historical Controls Evaluating Human Albumin Therapy in Mechanically Ventilated Patients With Sepsis-Associated Acute Respiratory Distress Syndrome
Sepsis-associated acute respiratory distress syndrome (ARDS) is a severe condition where severe infection causes fluid accumulation in the lungs, often requiring invasive mechanical ventilation. Patients with low blood albumin levels are particularly vulnerable to this fluid leakage, leading to prolonged dependence on a ventilator.
This observational study evaluates the association between a targeted human albumin treatment strategy combined with clinically guided fluid removal, and clinical outcomes in adults with sepsis-associated ARDS and low blood albumin levels (≤ 30 g/L).
Read more
Conducted at a single hospital, this study compares two groups. The prospective group consists of patients receiving current usual clinical care, where albumin administration and fluid management are determined by the treating clinical team. Their outcomes will be compared to a historical control group of similar patients who received standard care before this targeted albumin management strategy was routinely implemented.
The primary objective is to evaluate whether this targeted albumin strategy is associated with an increase in Ventilator-Free Days at day 28 (VFD-28). VFD-28 reflects both patient survival and successful liberation from the ventilator. The study will also observe secondary outcomes including oxygenation improvement, fluid balance, organ function, mortality, and safety events (e.g., fluid overload or allergic reactions). As an observational study, researchers do not assign treatments; all interventions are based on real-world clinical judgment.
Read the detailed description
Background and Rationale Hypoalbuminemia is common in patients with sepsis-associated ARDS and alters colloid osmotic pressure, exacerbating pulmonary edema and prolonging mechanical ventilation. While human albumin administration during the de-resuscitation phase may support intravascular volume and facilitate fluid removal (via diuretics or CRRT), real-world evidence evaluating a structured, targeted albumin strategy specifically in this vulnerable subpopulation remains limited.
Study Design and Cohorts This is a single-center, prospective observational study with a historical control cohort. The study employs a before-and-after design to evaluate real-world clinical outcomes.
Historical Control Cohort: Eligible patients identified retrospectively who received usual clinical care (primarily crystalloid-based fluid management) prior to the routine implementation of the targeted albumin strategy. Any occasional albumin use in this cohort will be documented and adjusted for in statistical analyses.
Prospective Observational Cohort: Eligible patients receiving current standard of care, which includes human albumin administration (aiming for serum albumin ≥ 30 g/L) and fluid de-resuscitation. Treatment decisions, including albumin dose, frequency, and fluid targets, remain entirely under the discretion of the treating clinical team.
Time Origin (Time Zero, T0) Definition To strictly prevent immortal time bias, the study time origin (T0) is defined as the exact timestamp when a patient simultaneously fulfills all required eligibility conditions: (1) Sepsis-3 criteria met, (2) ARDS criteria met, (3) invasive mechanical ventilation active, and (4) confirmed serum albumin ≤ 30 g/L. All baseline covariates, propensity score matching variables, and outcome observation windows strictly anchor to T0. If mechanical ventilation begins before T0, the actual ventilation start time is retained for the ventilation history but outcome computation (e.g., VFD-28) strictly starts at T0.
Exposure Definition (Observational Context) The primary exposure is management with a targeted human albumin strategy combined with fluid de-resuscitation. As an observational study, the protocol does not mandate therapy. Instead, it observes and records treatments delivered in routine clinical care. Data on albumin concentration, cumulative dose, fluid intake/output, diuretic use, and CRRT net ultrafiltration are prospectively collected.
Outcome Assessment and Statistical Analysis The primary outcome is Ventilator-Free Days at day 28 (VFD-28), calculated from T0. Patients who die within 28 days are assigned zero VFDs.
To mitigate confounding by indication and calendar time bias, a 1:1 Propensity Score Matching (PSM) will be utilized. Covariates (e.g., age, APACHE II, baseline SOFA, PaO2/FiO2, lactate, and cumulative fluid balance) are strictly restricted to pre-T0 values to avoid overadjustment by post-treatment mediators.
The primary outcome (VFD-28) will be analyzed evaluating the absolute difference between matched groups. As a key secondary analysis, a Fine-Gray competing-risk model will be used to evaluate the cumulative incidence of successful liberation from ventilation, treating death as a competing event. Repeated measures (e.g., albumin levels, oxygenation) will be evaluated using generalized estimating equations (GEE) or linear mixed-effects models (LMM).
- Conditions
- Acute Respiratory Distress Syndrome, Sepsis, Hypoalbuminemia
- Keywords
- Human Serum Albumin, Mechanical Ventilation, Fluid Management, De-resuscitation, Ventilator-Free Days
- Medical subject headings
- Respiratory Distress Syndrome, Sepsis, Hypoalbuminemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Observational Cohort | Patients enrolled prospectively receiving current usual clinical care, which includes a targeted human albumin treatment strategy (aiming to maintain serum albumin ≥ 30 g/L) combined with protocolized fluid de-resuscitation. Treatment decisions remain entirely under the discretion of the treating clinical team. | |
| Historical Control Cohort | Patients identified retrospectively from electronic medical records who received usual clinical care (primarily crystalloid-based fluid management without a targeted albumin protocol) prior to the routine implementation of the targeted albumin strategy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-Free Days at Day 28 (VFD-28)
VFD-28 is defined as the number of days from Time Zero (T0) to day 28 that a patient is alive and successfully liberated from invasive mechanical ventilation (defined as being free from the ventilator for at least 48 consecutive hours). Patients who die within the 28-day observation period are assigned zero VFDs, regardless of their ventilation status prior to death.
Measured: Up to 28 days from Time Zero (T0)
Cumulative Incidence of Successful Liberation from Ventilation
Analyzed using a competing-risk model (treating death as a competing event) to evaluate the probability of successful weaning from invasive mechanical ventilation.
Measured: Up to 28 days from Time Zero (T0)
Secondary outcomes (3)
Cumulative Fluid Balance
The daily net fluid balance evaluated to reflect the de-resuscitation trajectory. It is calculated by subtracting total fluid output (including net ultrafiltration from CRRT, if applicable) from total fluid intake.
Measured: From Day 1 to Day 7
Change in Oxygenation Index (PaO2/FiO2 Ratio)
The daily worst PaO2/FiO2 ratio measured to evaluate the trajectory of lung function and pulmonary edema resolution.
Measured: From Day 1 to Day 7
28-Day All-Cause Mortality
The proportion of patients who die from any cause within the 28-day observation period.
Measured: At Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Hainan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857928
- Sponsor's protocol ID
- 2026-K118-01
- Acronym
- ALB-SARDS
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.
PubMed 16714767Grasselli G, Calfee CS, Camporota L, Poole D, Amato MBP, Antonelli M, Arabi YM, Baroncelli F, Beitler JR, Bellani G, Bellingan G, Blackwood B, Bos LDJ, Brochard L, Brodie D, Burns KEA, Combes A, D'Arrigo S, De Backer D, Demoule A, Einav S, Fan E, Ferguson ND, Frat JP, Gattinoni L, Guerin C, Herridge MS, Hodgson C, Hough CL, Jaber S, Juffermans NP, Karagiannidis C, Kesecioglu J, Kwizera A, Laffey JG, Mancebo J, Matthay MA, McAuley DF, Mercat A, Meyer NJ, Moss M, Munshi L, Myatra SN, Ng Gong M, Papazian L, Patel BK, Pellegrini M, Perner A, Pesenti A, Piquilloud L, Qiu H, Ranieri MV, Riviello E, Slutsky AS, Stapleton RD, Summers C, Thompson TB, Valente Barbas CS, Villar J, Ware LB, Weiss B, Zampieri FG, Azoulay E, Cecconi M; European Society of Intensive Care Medicine Taskforce on ARDS. ESICM guidelines on acute respiratory distress syndrome: definition, phenotyping and respiratory support strategies. Intensive Care Med. 2023 Jul;49(7):727-759. doi: 10.1007/s00134-023-07050-7. Epub 2023 Jun 16.
PubMed 37326646Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
PubMed 34599691Sakr Y, Nierhaus A, Schumacher U, Utzolino S, Jaschinski U, Petros S, Fichtner F, Eimer C, Putensen C, Tanev I, Kreienbuhl L, Kluge S, Kousoulas L, Kuhn SO, Jarczak D, Quintel M, Bauer M; SepNet Critical Care Trials Group and Albumin Replacement Therapy in Septic Shock (ARISS) investigators. Albumin Replacement Therapy in Septic Shock: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2559297. doi: 10.1001/jamanetworkopen.2025.59297.
PubMed 41712212Williams JM, Greenslade JH, Hills AZ, Ray MT. Intervention With Concentrated Albumin for Undifferentiated Sepsis in the Emergency Department (ICARUS-ED): A Pilot Randomized Controlled Trial. Ann Emerg Med. 2025 Jul;86(1):59-69. doi: 10.1016/j.annemergmed.2024.12.016. Epub 2025 Jan 23.
PubMed 39846907Gray AJ, Oatey K, Grahamslaw J, Irvine S, Cafferkey J, Kennel T, Norrie J, Walsh T, Lone N, Horner D, Appelboam A, Hall P, Skipworth RJE, Bell D, Rooney K, Shankar-Hari M, Corfield AR; Albumin, Balanced, and Crystalloid-Sepsis (ABC-Sepsis) Investigators. Albumin Versus Balanced Crystalloid for the Early Resuscitation of Sepsis: An Open Parallel-Group Randomized Feasibility Trial- The ABC-Sepsis Trial. Crit Care Med. 2024 Oct 1;52(10):1520-1532. doi: 10.1097/CCM.0000000000006348. Epub 2024 Jun 24.
PubMed 38912884Hadar L, Sood S. When knowledge is demotivating: subjective knowledge and choice overload. Psychol Sci. 2014 Sep;25(9):1739-47. doi: 10.1177/0956797614539165. Epub 2014 Jul 18.
PubMed 25037963Boardman K, Kelpe M, Straub D, VanFleet R. Shining through a merger. Nurs Manage. 2003 May;34(5):45-8. doi: 10.1097/00006247-200305000-00012.
PubMed 12771687Finfer S, Bellomo R, Boyce N, French J, Myburgh J, Norton R; SAFE Study Investigators. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med. 2004 May 27;350(22):2247-56. doi: 10.1056/NEJMoa040232.
PubMed 15163774Cusack RAF, Rodriguez A, Cantan B, Garduno A, Connolly E, Zilahi G, Coakley JD, Martin-Loeches I. Microcirculation properties of 20 % albumin in sepsis; a randomised controlled trial. J Crit Care. 2025 Jun;87:155039. doi: 10.1016/j.jcrc.2025.155039. Epub 2025 Feb 27.
PubMed 40020556Wiedermann CJ. Phases of fluid management and the roles of human albumin solution in perioperative and critically ill patients. Curr Med Res Opin. 2020 Dec;36(12):1961-1973. doi: 10.1080/03007995.2020.1840970. Epub 2020 Nov 5.
PubMed 33090028Aman J, van der Heijden M, van Lingen A, Girbes AR, van Nieuw Amerongen GP, van Hinsbergh VW, Groeneveld AB. Plasma protein levels are markers of pulmonary vascular permeability and degree of lung injury in critically ill patients with or at risk for acute lung injury/acute respiratory distress syndrome. Crit Care Med. 2011 Jan;39(1):89-97. doi: 10.1097/CCM.0b013e3181feb46a.
PubMed 21057316Fernandez-Sarmiento J, Hernandez-Sarmiento R, Salazar MP, Barrera S, Castilla V, Duque C. The association between hypoalbuminemia and microcirculation, endothelium, and glycocalyx disorders in children with sepsis. Microcirculation. 2023 Nov;30(8):e12829. doi: 10.1111/micc.12829. Epub 2023 Aug 28.
PubMed 37639384Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med. 2003 Apr 17;348(16):1546-54. doi: 10.1056/NEJMoa022139.
PubMed 12700374Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study With Historical Controls Evaluating Human Albumin Therapy in Mechanically Ventilated Patients With Sepsis-Associated Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07857928
- Acronym / sponsor ID
- ALB-SARDS / 2026-K118-01
- Conditions
- Acute Respiratory Distress Syndrome, Sepsis, Hypoalbuminemia
- Keywords
- Human Serum Albumin, Mechanical Ventilation, Fluid Management, De-resuscitation, Ventilator-Free Days
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Hainan Medical UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Oct 2026 (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-associated acute respiratory distress syndrome (ARDS) is a severe condition where severe infection causes fluid accumulation in the lungs, often requiring invasive mechanical ventilation. Patients with low blood albumin levels are particularly vulnerable to this fluid leakage, leading to prolonged dependence on a ventilator.
This observational study evaluates the association between a targeted human albumin treatment strategy combined with clinically guided fluid removal, and clinical outcomes in adults with sepsis-associated ARDS and low blood albumin levels (≤ 30 g/L).
Conducted at a single hospital, this study compares two groups. The prospective group consists of patients receiving current usual clinical care, where albumin administration and fluid management are determined by the treating clinical team. Their outcomes will be compared to a historical control group of similar patients who received standard care before this targeted albumin management strategy was routinely implemented.
The primary objective is to evaluate whether this targeted albumin strategy is associated with an increase in Ventilator-Free Days at day 28 (VFD-28). VFD-28 reflects both patient survival and successful liberation from the ventilator. The study will also observe secondary outcomes including oxygenation improvement, fluid balance, organ function, mortality, and safety events (e.g., fluid overload or allergic reactions). As an observational study, researchers do not assign treatments; all interventions are based on real-world clinical judgment.
Detailed description
Background and Rationale Hypoalbuminemia is common in patients with sepsis-associated ARDS and alters colloid osmotic pressure, exacerbating pulmonary edema and prolonging mechanical ventilation. While human albumin administration during the de-resuscitation phase may support intravascular volume and facilitate fluid removal (via diuretics or CRRT), real-world evidence evaluating a structured, targeted albumin strategy specifically in this vulnerable subpopulation remains limited.
Study Design and Cohorts This is a single-center, prospective observational study with a historical control cohort. The study employs a before-and-after design to evaluate real-world clinical outcomes.
Historical Control Cohort: Eligible patients identified retrospectively who received usual clinical care (primarily crystalloid-based fluid management) prior to the routine implementation of the targeted albumin strategy. Any occasional albumin use in this cohort will be documented and adjusted for in statistical analyses.
Prospective Observational Cohort: Eligible patients receiving current standard of care, which includes human albumin administration (aiming for serum albumin ≥ 30 g/L) and fluid de-resuscitation. Treatment decisions, including albumin dose, frequency, and fluid targets, remain entirely under the discretion of the treating clinical team.
Time Origin (Time Zero, T0) Definition To strictly prevent immortal time bias, the study time origin (T0) is defined as the exact timestamp when a patient simultaneously fulfills all required eligibility conditions: (1) Sepsis-3 criteria met, (2) ARDS criteria met, (3) invasive mechanical ventilation active, and (4) confirmed serum albumin ≤ 30 g/L. All baseline covariates, propensity score matching variables, and outcome observation windows strictly anchor to T0. If mechanical ventilation begins before T0, the actual ventilation start time is retained for the ventilation history but outcome computation (e.g., VFD-28) strictly starts at T0.
Exposure Definition (Observational Context) The primary exposure is management with a targeted human albumin strategy combined with fluid de-resuscitation. As an observational study, the protocol does not mandate therapy. Instead, it observes and records treatments delivered in routine clinical care. Data on albumin concentration, cumulative dose, fluid intake/output, diuretic use, and CRRT net ultrafiltration are prospectively collected.
Outcome Assessment and Statistical Analysis The primary outcome is Ventilator-Free Days at day 28 (VFD-28), calculated from T0. Patients who die within 28 days are assigned zero VFDs.
To mitigate confounding by indication and calendar time bias, a 1:1 Propensity Score Matching (PSM) will be utilized. Covariates (e.g., age, APACHE II, baseline SOFA, PaO2/FiO2, lactate, and cumulative fluid balance) are strictly restricted to pre-T0 values to avoid overadjustment by post-treatment mediators.
The primary outcome (VFD-28) will be analyzed evaluating the absolute difference between matched groups. As a key secondary analysis, a Fine-Gray competing-risk model will be used to evaluate the cumulative incidence of successful liberation from ventilation, treating death as a competing event. Repeated measures (e.g., albumin levels, oxygenation) will be evaluated using generalized estimating equations (GEE) or linear mixed-effects models (LMM).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Observational Cohort | – | –Patients enrolled prospectively receiving current usual clinical care, which includes a targeted human albumin treatment strategy (aiming to maintain serum albumin ≥ 30 g/L) combined with protocolized fluid de-resuscitation. Treatment decisions remain entirely under the discretion of the treating clinical team. |
| Historical Control Cohort | – | –Patients identified retrospectively from electronic medical records who received usual clinical care (primarily crystalloid-based fluid management without a targeted albumin protocol) prior to the routine implementation of the targeted albumin strategy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises critically ill adult patients admitted to the intensive care units (ICUs) at the Second Affiliated Hospital of Hainan Medical University. Eligible participants are those diagnosed with sepsis-associated acute respiratory distress syndrome (ARDS) who require invasive mechanical ventilation and have confirmed hypoalbuminemia (serum albumin ≤ 30 g/L). The prospective cohort is identified consecutively from active ICU admissions, while the historical control cohort is identified retrospectively from electronic medical records of patients admitted prior to the routine implementation of the targeted albumin protocol.
Key inclusion criteria (7 listed)
- Aged 18 years or older.
- Clinical diagnosis conforming to the Sepsis-3 consensus criteria.
- Diagnosis of acute respiratory distress syndrome (ARDS) fulfilling the European Society of Intensive Care Medicine (ESICM) criteria (mild, moderate, or severe).
- Receiving invasive mechanical ventilation, with an intubation duration ≤ 48 hours at study enrollment.
- First admission to the intensive care unit (ICU) ≤ 24 hours prior to enrollment.
Key exclusion criteria (6 listed)
- Female patients who are pregnant or lactating.
- Severe burn injury or currently receiving extracorporeal membrane oxygenation (ECMO) support.
- Perioperative period of liver transplantation or decompensated liver cirrhosis (Child-Pugh class C).
- End-stage malignancy or an estimated clinical life expectancy < 3 months.
- Signed Do-Not-Resuscitate (DNR) order, agreement to withhold/withdraw active life-sustaining therapy, or moribund state expected to result in death within 24 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ventilator-Free Days at Day 28 (VFD-28)
Time frame: Up to 28 days from Time Zero (T0)
VFD-28 is defined as the number of days from Time Zero (T0) to day 28 that a patient is alive and successfully liberated from invasive mechanical ventilation (defined as being free from the ventilator for at least 48 consecutive hours). Patients who die within the 28-day observation period are assigned zero VFDs, regardless of their ventilation status prior to death.
Cumulative Incidence of Successful Liberation from Ventilation
Time frame: Up to 28 days from Time Zero (T0)
Analyzed using a competing-risk model (treating death as a competing event) to evaluate the probability of successful weaning from invasive mechanical ventilation.
3 secondary outcomes
Cumulative Fluid Balance
Time frame: From Day 1 to Day 7
Change in Oxygenation Index (PaO2/FiO2 Ratio)
Time frame: From Day 1 to Day 7
28-Day All-Cause Mortality
Time frame: At Day 28
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 13 Oct 2026.
- Background: PubMed 16714767National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.
- Background: PubMed 37326646Grasselli G, Calfee CS, Camporota L, Poole D, Amato MBP, Antonelli M, Arabi YM, Baroncelli F, Beitler JR, Bellani G, Bellingan G, Blackwood B, Bos LDJ, Brochard L, Brodie D, Burns KEA, Combes A, D'Arrigo S, De Backer D, Demoule A, Einav S, Fan E, Ferguson ND, Frat JP, Gattinoni L, Guerin C, Herridge MS, Hodgson C, Hough CL, Jaber S, Juffermans NP, Karagiannidis C, Kesecioglu J, Kwizera A, Laffey JG, Mancebo J, Matthay MA, McAuley DF, Mercat A, Meyer NJ, Moss M, Munshi L, Myatra SN, Ng Gong M, Papazian L, Patel BK, Pellegrini M, Perner A, Pesenti A, Piquilloud L, Qiu H, Ranieri MV, Riviello E, Slutsky AS, Stapleton RD, Summers C, Thompson TB, Valente Barbas CS, Villar J, Ware LB, Weiss B, Zampieri FG, Azoulay E, Cecconi M; European Society of Intensive Care Medicine Taskforce on ARDS. ESICM guidelines on acute respiratory distress syndrome: definition, phenotyping and respiratory support strategies. Intensive Care Med. 2023 Jul;49(7):727-759. doi: 10.1007/s00134-023-07050-7. Epub 2023 Jun 16.
- Background: PubMed 34599691Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
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- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and Sepsis, run by The Second Affiliated Hospital of Hainan Medical University at 1 site in China.
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 7 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: opening soon, as of the sponsor's last update on 13 Oct 2026. 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 China. 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?
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 Fengyun Wang, MD/PhD (8619389918115, dr-w@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-Free Days at Day 28 (VFD-28) (time frame: Up to 28 days from Time Zero (T0)). The study lists 2 primary outcomes in all. 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 NCT07857928, which also lists 15 linked publications.
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 13 Oct 2026.