Prognosis Prediction of Sepsis in Icu PatientsNCT07289906
Measurement of Mass Change in Serum Albumin Compared to Serum Lactic Acid as Predictive Tool for Sepsis Prognosis in Non Surgical ICU Patients
An observational study of Prognosis Prediction of Sepsis in Icu Patients, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to assess the reliability of measurement of mass change in serum albumin compared to serum lactic acid as predictive tool for sepsis prognosis in nonsurgical ICU patients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prognosis Prediction of Sepsis in Icu Patients
- What is being tested?
- Mass change in serum albumin
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Sep 2025to 28 Sep 2026
- 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 70 years
- All sexes
- Adult, Older adult
Study population: A prospective cohort study is planned, aiming to enroll a minimum of 40 patients. The sample size calculation is based on findings from Mahashabde et al. (2024), which reported that the predictive accuracy of serum lactase for septic shock at admission had an AUC ROC of 0.96, while serum albumin had an AUC ROC of 0.323. The anticipated incidence of septic shock is 42%, as reported in the EPIC ill study (2019). The sample size was calculated to achieve 100% statistical power with a significance level (alpha) of 0.05.
Who may be able to join
- Adults aged ≥18 year 70 years. Diagnosis of sepsis according to survival sepsis campaign(SSC). Patients admitted for medical (non-surgical) conditions.
Who cannot join
- Chronic liver disease or cirrhosis. Hyperalbuminuria (ex: nephrotic syndrome, nephritic syndrome). Terminal illness with an expected survival of less than 24 hours. Refusal or inability to obtain informed consent from patients or their care givers.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the reliability of measurement of mass change in serum albumin compared to serum lactic acid as predictive tool for sepsis prognosis in nonsurgical ICU patients
Read the detailed description
This study explores the prognostic value of mass change in serum albumin compared to serum lactic acid levels in non-surgical ICU patients with sepsis. While serum lactate is an established marker of tissue hypo-perfusion and a predictor of sepsis outcomes, serum albumin is less frequently used for dynamic monitoring, although it is known to correlate with severity and mortality
Measurements:
Data Collection:
A-Baseline Data on ICU Admission:
- Demographics: age, sex
- Comorbidities (e.g., diabetes, hypertension, chronic kidney disease)
- Initial hemodynamic parameters (BP-HR-SO2-ECG-UOP-TEMP-RR)
- diagnosis of sepsis involves recognising signs of infection plus organ dysfunction according to SSC and sepsis -3 A- Search about source of infection by:
- History of present illness about main complain.
- clinical examination
- investigation a. labs (CBC (containing TLC and platlets), CRP, Procal, BloodGases (containing serum lactate), Urea, serum Creatinine, TotaL bilirubin, Urine Analysis, Pan culture, AST, ALT) b-imaging (chest x.ray) B- organ dysfunction Defined as increase increase in SOFA (Sequential Organ Failure Assessment) score >=2 points from baseline. SOFA Score range: 0-6: low risk of organ failure 7-12: moderate risk >12: high risk of mortality
- initial reading of serum albumin in admission (T0)
- initial reading of albumin creat ratio (ACR)as tool for measuring albumin in urine Patients with severe albuminuria will be excluded from the study
Daily measurements:
- Average of 24 HR (BP, HR, SO2, TEMP, RR,)
- CBC, CRP, serum urea, serum creatinine, Total bilirubin, serum Albumin, blood gases (containing serum lactate)
3-24HR Fluid balance.
- ACR will be measured every 3days during study to predict any abnormal increase in albumin loss in urine
C- Daily recordings:
- SOFA score.
- mass changes in serum albumin (T0-T1, T1-T2, T3-T2……...ETC).
- serum lactate.
- vasopressor use.
- Being tested
- Mass change in serum albumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mass change in serum albuminDiagnostic test
Also called Serum lactate
study aims to assess the accuracy of measurement of mass change in serum albumin compared to serum lactic acid as predictive tool for sepsis prognosis in nonsurgical ICU patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative value between mass change in serum albumin and serum lactate in prediction of sepsis prognosis (discharge or mortality)
Knowing Which is more accurate in predicting the prognosis of sepsis between mass change in serum albumin and serum lactic acid in non surgical icu patients
Measured: 12 months
Secondary outcomes (1)
Duration of vasopressor use and its correlation to prognosis of sepsis.
If long duration of using vasopressor correlate with prognosis of sepsis
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start28 Sep 2025
- Primary completion28 Sep 2026 (estimated)
- Study completion28 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prognosis Prediction of Sepsis in Icu PatientsStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alaa E Mohamed Hassen, Prof, Study director, Department of anesthesia ,Intensive Care and pain management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289906
- Sponsor's protocol ID
- MD241/2025
- Status last verified
- Nov 2025
- First submitted
- 5 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Mass Change in Serum Albumin Compared to Serum Lactic Acid as Predictive Tool for Sepsis Prognosis in Non Surgical ICU Patients
- ClinicalTrials.gov ID
- NCT07289906
- Acronym / sponsor ID
- MD241/2025
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 28 Sep 2025 (actual)
- Primary completion
- 28 Sep 2026 (estimated)
- Study completion
- 28 Sep 2026 (estimated)
- First posted
- 17 Dec 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.
This study aims to assess the reliability of measurement of mass change in serum albumin compared to serum lactic acid as predictive tool for sepsis prognosis in nonsurgical ICU patients
Detailed description
This study explores the prognostic value of mass change in serum albumin compared to serum lactic acid levels in non-surgical ICU patients with sepsis. While serum lactate is an established marker of tissue hypo-perfusion and a predictor of sepsis outcomes, serum albumin is less frequently used for dynamic monitoring, although it is known to correlate with severity and mortality
Measurements:
Data Collection:
A-Baseline Data on ICU Admission:
- Demographics: age, sex
- Comorbidities (e.g., diabetes, hypertension, chronic kidney disease)
- Initial hemodynamic parameters (BP-HR-SO2-ECG-UOP-TEMP-RR)
- diagnosis of sepsis involves recognising signs of infection plus organ dysfunction according to SSC and sepsis -3 A- Search about source of infection by:
- History of present illness about main complain.
- clinical examination
- investigation a. labs (CBC (containing TLC and platlets), CRP, Procal, BloodGases (containing serum lactate), Urea, serum Creatinine, TotaL bilirubin, Urine Analysis, Pan culture, AST, ALT) b-imaging (chest x.ray) B- organ dysfunction Defined as increase increase in SOFA (Sequential Organ Failure Assessment) score >=2 points from baseline. SOFA Score range: 0-6: low risk of organ failure 7-12: moderate risk >12: high risk of mortality
- initial reading of serum albumin in admission (T0)
- initial reading of albumin creat ratio (ACR)as tool for measuring albumin in urine Patients with severe albuminuria will be excluded from the study
Daily measurements:
- Average of 24 HR (BP, HR, SO2, TEMP, RR,)
- CBC, CRP, serum urea, serum creatinine, Total bilirubin, serum Albumin, blood gases (containing serum lactate)
3-24HR Fluid balance.
- ACR will be measured every 3days during study to predict any abnormal increase in albumin loss in urine
C- Daily recordings:
- SOFA score.
- mass changes in serum albumin (T0-T1, T1-T2, T3-T2……...ETC).
- serum lactate.
- vasopressor use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A prospective cohort study is planned, aiming to enroll a minimum of 40 patients. The sample size calculation is based on findings from Mahashabde et al. (2024), which reported that the predictive accuracy of serum lactase for septic shock at admission had an AUC ROC of 0.96, while serum albumin had an AUC ROC of 0.323. The anticipated incidence of septic shock is 42%, as reported in the EPIC ill study (2019). The sample size was calculated to achieve 100% statistical power with a significance level (alpha) of 0.05.
Key inclusion criteria (1 listed)
- Adults aged ≥18 year 70 years. Diagnosis of sepsis according to survival sepsis campaign(SSC). Patients admitted for medical (non-surgical) conditions.
Key exclusion criteria (1 listed)
- Chronic liver disease or cirrhosis. Hyperalbuminuria (ex: nephrotic syndrome, nephritic syndrome). Terminal illness with an expected survival of less than 24 hours. Refusal or inability to obtain informed consent from patients or their care givers.
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 |
|---|---|---|
| Mass change in serum albuminAlso: Serum lactatestudy aims to assess the accuracy of measurement of mass change in serum albumin compared to serum lactic acid as predictive tool for sepsis prognosis in nonsurgical ICU patients | Diagnostic test | – |
Primary outcome
Comparative value between mass change in serum albumin and serum lactate in prediction of sepsis prognosis (discharge or mortality)
Time frame: 12 months
Knowing Which is more accurate in predicting the prognosis of sepsis between mass change in serum albumin and serum lactic acid in non surgical icu patients
1 secondary outcome
Duration of vasopressor use and its correlation to prognosis of sepsis.
Time frame: 12months
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 17 Dec 2025.
- Individual participant dataSharing planned: No
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.
Alaa E Mohamed Hassen, Prof study director
Department of anesthesia ,Intensive Care and pain management
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 Prognosis Prediction of Sepsis in Icu Patients, run by Ain Shams University 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Dec 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 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?
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?
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?
Comparative value between mass change in serum albumin and serum lactate in prediction of sepsis prognosis (discharge or mortality) (time frame: 12 months). 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 17 Dec 2025.