SepsisNCT06556914
Effect of Albumin Replacement on Oxygen Delivery in Sepsis Patients
An observational study of Sepsis and Intensive Care Unit, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
Fluid resuscitation is a critical component of sepsis treatment. Research has shown that intravenous (IV) fluid therapy in sepsis positively impacts cardiac output and thereby oxygen (O2) delivery through a complex interaction of central venous pressure, right atrial pressure, venous resistance, ventricular… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Intensive Care Unit
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 15 Mar 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Arterial oxygen saturation (SaO2), hemoglobin (Hb), partial pressure of oxygen in the arterial blood (PaO2) values will be obtained by blood gas measurements. Cardiac output will be calculated from the parasternal long axis window by transthoracic echocardiography and left ventricular outflow tract (LVOT) measurement. LVOT peak velocity measurement (VTI) will be displayed in PulseWave mode through the apical 5-window window. During measurement, the image will be frozen and VTI will be measured from the widest wave. The effect of albumin replacement on the measurements will be evaluated by calculating the ECHO findings, blood gas parameters and SOFA score of the study patients before and after albumin replacement.
Who may be able to join
- Followed up with a diagnosis of sepsis,
- over 18 years old
- Patients who were diagnosed with hypo-albuminemia after more than 4L/day fluid resuscitation and underwent albumin replacement
Who cannot join
- Consent is not given by the patient or his/her guardian,
- The initial cause of shock was hypovolemic, cardiogenic or obstructive shock.
- Pregnancy or suspected pregnancy
- Peripheral limb or severe organ ischemia with peripheral artery disease
- Cardiac functions cannot be evaluated optimally by transthoracic echocardiography
- Patients who died within the first 24 hours after intensive care admission
Trial locations and contacts
1 site in 1 country.
About this study
Fluid resuscitation is a critical component of sepsis treatment. Research has shown that intravenous (IV) fluid therapy in sepsis positively impacts cardiac output and thereby oxygen (O2) delivery through a complex interaction of central venous pressure, right atrial pressure, venous resistance, ventricular compliance, cardiac contractility, and systemic vascular resistance. The 2021 sepsis prevention guidelines recommend balanced crystalloids as first-line therapy. However, no studies in the literature have evaluated the effect of albumin on O2 delivery. In our study, the investigators aim to assess the impact of albumin replacement on O2 delivery in sepsis patients in the intensive care unit.
Read the detailed description
Patients will be admitted from the emergency room, operating room or medical wards. After obtaining written consent from the patients or their guardians, patients who are followed up in the intensive care unit with a diagnosis of sepsis, patients over the age of 18, who are diagnosed with hypo-albuminemia after more than 4 L/day fluid resuscitation and who undergo albumin replacement will be included in the study. Treatment support for sepsis patients will be organized according to international guidelines and our local protocol, with appropriate antibiotic therapy, fluid infusion (Crystalloids 20 mL/Kg), norepinephrine infusion to keep mean arterial pressure (MAP)>65 mmHg, and infection source control. Demographic information of the patients, sepsis cause, systemic diseases, surgical history, Sequential Organ Failure Assessment (SOFA) score, which shows the severity of the disease, Acute Physiology and Chronic Health Evaluation (APACHE II) score, hemodynamic variables, blood gas parameters, complete blood count and blood biochemistry. values, total daily fluid intake and excretion, and daily fluid balance will be recorded.
For patients with a plasma albumin value below 2.5 d/dL who require 4 L or more of crystalloid per day, 20% Albumin (100 mL) will be administered as an intravenous infusion over a minimum of 15 minutes once a day for 3 days.The effect of albumin replacement on the measurements will be evaluated by calculating the ECHO findings, blood gas parameters and SOFA score of the study patients before and after albumin replacement. Oxygen delivery will be calculated 6 times in total for 3 days and the SOFA score will be calculated 3 times in total once a day.
- Conditions
- Sepsis, Intensive Care Unit
- Keywords
- oxygen delivery, Sepsis, albumin deficiency
- Medical subject headings
- Sepsis
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 |
|---|---|---|
| group albumin | The effect of albumin replacement on the measurements will be evaluated by calculating the ECHO findings, blood gas parameters and SOFA score of the study patients before and after albumin replacement. Oxygen delivery will be calculated 6 times in total for 3 days and the SOFA score will be calculated 3 times in total once a day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen delivery
Effect of albumin replacement on oxygen delivery.Arterial oxygen saturation (SaO2), hemoglobin (Hb), partial pressure of oxygen in the arterial blood (PaO2) values will be obtained by blood gas measurements.DO2(oxygen delivery): CO x 10 x (Hbx1,34x SaO2) When oxygen delivery to tissue is calculated according to this formula, normal values are 5 x 10 x 15 x 1,34 x 0.98 =984 ml/dk.
Measured: Up to 1 hour after albumin replacement
Secondary outcomes (1)
change in SOFA score
Effect of albumin replacement on change in SOFA score. By evaluating the Central nervous system, Cardiovascular system, Respiratory system, Coagulation, Liver and Renal function, each organ system receives a score ranging from 0 (normal) to 4 (most abnormal), with a minimum SOFA score of 0 and a maximum SOFA score of 24.
Measured: Up to 12 hour after albumin replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start15 Nov 2024
- Primary completion5 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- gamze MD ertaş, specialist, Principal investigator, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556914
- Sponsor's protocol ID
- albumin do2
- Status last verified
- Jul 2026
- First submitted
- 13 Aug 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shasthry SM, Kumar M, Khumuckham JS, Sarin SK. Changes in cardiac output and incidence of volume overload in cirrhotics receiving 20% albumin infusion. Liver Int. 2017 Aug;37(8):1167-1176. doi: 10.1111/liv.13375. Epub 2017 Mar 5.
PubMed 28135785
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Albumin Replacement on Oxygen Delivery in Sepsis Patients
- ClinicalTrials.gov ID
- NCT06556914
- Acronym / sponsor ID
- albumin do2
- Conditions
- Sepsis, Intensive Care Unit
- Keywords
- oxygen delivery, Sepsis, albumin deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 16 Aug 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.
Fluid resuscitation is a critical component of sepsis treatment. Research has shown that intravenous (IV) fluid therapy in sepsis positively impacts cardiac output and thereby oxygen (O2) delivery through a complex interaction of central venous pressure, right atrial pressure, venous resistance, ventricular compliance, cardiac contractility, and systemic vascular resistance. The 2021 sepsis prevention guidelines recommend balanced crystalloids as first-line therapy. However, no studies in the literature have evaluated the effect of albumin on O2 delivery. In our study, the investigators aim to assess the impact of albumin replacement on O2 delivery in sepsis patients in the intensive care unit.
Detailed description
Patients will be admitted from the emergency room, operating room or medical wards. After obtaining written consent from the patients or their guardians, patients who are followed up in the intensive care unit with a diagnosis of sepsis, patients over the age of 18, who are diagnosed with hypo-albuminemia after more than 4 L/day fluid resuscitation and who undergo albumin replacement will be included in the study. Treatment support for sepsis patients will be organized according to international guidelines and our local protocol, with appropriate antibiotic therapy, fluid infusion (Crystalloids 20 mL/Kg), norepinephrine infusion to keep mean arterial pressure (MAP)>65 mmHg, and infection source control. Demographic information of the patients, sepsis cause, systemic diseases, surgical history, Sequential Organ Failure Assessment (SOFA) score, which shows the severity of the disease, Acute Physiology and Chronic Health Evaluation (APACHE II) score, hemodynamic variables, blood gas parameters, complete blood count and blood biochemistry. values, total daily fluid intake and excretion, and daily fluid balance will be recorded.
For patients with a plasma albumin value below 2.5 d/dL who require 4 L or more of crystalloid per day, 20% Albumin (100 mL) will be administered as an intravenous infusion over a minimum of 15 minutes once a day for 3 days.The effect of albumin replacement on the measurements will be evaluated by calculating the ECHO findings, blood gas parameters and SOFA score of the study patients before and after albumin replacement. Oxygen delivery will be calculated 6 times in total for 3 days and the SOFA score will be calculated 3 times in total once a day.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group albumin | – | –The effect of albumin replacement on the measurements will be evaluated by calculating the ECHO findings, blood gas parameters and SOFA score of the study patients before and after albumin replacement. Oxygen delivery will be calculated 6 times in total for 3 days and the SOFA score will be calculated 3 times in total once a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Arterial oxygen saturation (SaO2), hemoglobin (Hb), partial pressure of oxygen in the arterial blood (PaO2) values will be obtained by blood gas measurements. Cardiac output will be calculated from the parasternal long axis window by transthoracic echocardiography and left ventricular outflow tract (LVOT) measurement. LVOT peak velocity measurement (VTI) will be displayed in PulseWave mode through the apical 5-window window. During measurement, the image will be frozen and VTI will be measured from the widest wave. The effect of albumin replacement on the measurements will be evaluated by calculating the ECHO findings, blood gas parameters and SOFA score of the study patients before and after albumin replacement.
Key inclusion criteria (3 listed)
- Followed up with a diagnosis of sepsis,
- over 18 years old
- Patients who were diagnosed with hypo-albuminemia after more than 4L/day fluid resuscitation and underwent albumin replacement
Key exclusion criteria (6 listed)
- Consent is not given by the patient or his/her guardian,
- The initial cause of shock was hypovolemic, cardiogenic or obstructive shock.
- Pregnancy or suspected pregnancy
- Peripheral limb or severe organ ischemia with peripheral artery disease
- Cardiac functions cannot be evaluated optimally by transthoracic echocardiography
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
oxygen delivery
Time frame: Up to 1 hour after albumin replacement
Effect of albumin replacement on oxygen delivery.Arterial oxygen saturation (SaO2), hemoglobin (Hb), partial pressure of oxygen in the arterial blood (PaO2) values will be obtained by blood gas measurements.DO2(oxygen delivery): CO x 10 x (Hbx1,34x SaO2) When oxygen delivery to tissue is calculated according to this formula, normal values are 5 x 10 x 15 x 1,34 x 0.98 =984 ml/dk.
1 secondary outcome
change in SOFA score
Time frame: Up to 12 hour after albumin replacement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 28135785Shasthry SM, Kumar M, Khumuckham JS, Sarin SK. Changes in cardiac output and incidence of volume overload in cirrhotics receiving 20% albumin infusion. Liver Int. 2017 Aug;37(8):1167-1176. doi: 10.1111/liv.13375. Epub 2017 Mar 5.
- Individual participant dataSharing planned: Undecided
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
gamze MD ertaş, specialist principal investigator
Samsun University
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 Sepsis and Intensive Care Unit, run by Samsun University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 7 Jul 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen delivery (time frame: Up to 1 hour after albumin replacement). 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 NCT06556914, which also lists 1 linked publication.
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 7 Jul 2026.