SepsisNCT05810415
Use of Renin Versus Lactic Acid as Tissue Perfusion Biomarkers for Mortality Prediction in Hypotensive Critically Ill Patients
An observational study of Sepsis and Obstructive Shock, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
Measurement of Whole Blood Lactate Concentrations Whole blood lactate concentrations will be measured at the time of study enrollment and at 24, 48, and 72 hours. Measurement of Plasma Renin Concentrations Serum renin concentration will be measured on blood samples drawn from arterial catheters on supine position… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Sepsis, Obstructive Shock, Critical Illness
- What is being tested?
- Renin levels and lactic acid levels
- How many people
- 84 participants
- Where
- 2 sitesEgypt
- Study dates
- 21 Jun 2022to 25 Jan 2024
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study will be conducted at Al-Azhar university hospitals at intensive care unit (ICU). Patients can be enrolled at any point during their admission. The patients are followed once enrolled and the data are recorded till death or end of ICU stay by dedicated investigator
Who may be able to join
- Patients aged 21-60 years old
- Those receiving vasopressors for greater than or equal to 6 hours to maintain a mean arterial pressure (MAP) ≥65 mm Hg.
- Anticipated stay >24 hours.
Who cannot join
- Patients or families refusing to participate in the study.
- Patients on renal replacement therapy.
- Patients receiving betablockers
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 1 recruiting
- Completed
Azhar unversity
Cairo
- Recruiting
Azhar University
Madīnat an Naşr, Cairo Governorate, 11765
Abd El-Wahab AS Mohammed, AP, abdelwahabsaleh7020@gmail.com
About this study
Measurement of Whole Blood Lactate Concentrations Whole blood lactate concentrations will be measured at the time of study enrollment and at 24, 48, and 72 hours. Measurement of Plasma Renin Concentrations Serum renin concentration will be measured on blood samples drawn from arterial catheters on supine position right after inclusion. Discarded whole blood samples (waste blood samples) in EDTA tubes are prospectively collected from each patient at the time of study enrollment and at 24, 48, and 72 hours.
Read the detailed description
Elevated renin-levels in critically ill patients are associated with worse outcomes and outperform lactate as a prognostic indicator of survival. Using biomarkers to understand patient trajectory in the ICU has high utility.
Both whole blood lactate concentration and lactate clearance yield meaningful information, but lactate can be an insensitive prognostic marker. Renin has recently emerged as a prognostic marker for ICU mortality.
AIM OF THE WORK Evaluation of serum renin level to determine if it performs well as a marker of tissue-perfusion and prediction of mortality of critically ill patients in intensive care unit in comparison with serum lactate.
a prospective observational study will be conducted.. Patients can be enrolled at any point during their admission. The patients are followed once enrolled and the data are recorded till death or end of ICU stay by dedicated investigator. Primary and secondary outcomes will be analyzed after completing of the study.
Plasma renin concentrations and Whole blood lactate concentrations are measured at enrollment and at 24, 48, and 72 hours.
Measurements
- Patient characteristics: including age, sex, chronic health conditions, weight.
- Reasons of ICU admission.
- length of stay in days (ICU and hospital).
- Mortality (ICU and in-hospital).
- Physiologic data: including heart rate, mean arterial blood pressure (MAP), temperature, respiratory rate, PaO2, FIO2, hematocrit, WBC count, serum creatinine, urine output, blood urea nitrogen, sodium, albumin, bilirubin, glucose, arterial carbon dioxide tension, pH, and the total Glasgow Coma Scale score.
- The need for mechanical ventilation and renal replacement therapy.
- Patient outcome either survivor or not survivor. Measurement of Whole Blood Lactate Concentrations Whole blood lactate concentrations will be measured at the time of study enrollment and at 24, 48, and 72 hours.
Measurement of Plasma Renin Concentrations Serum renin concentration will be measured on blood samples drawn from arterial catheters on supine position right after inclusion.
Discarded whole blood samples (waste blood samples) in EDTA tubes are prospectively collected from each patient at the time of study enrollment and at 24, 48, and 72 hours.
Samples will be centrifuged to yield 2mL of EDTA plasma and then stored at -20°C. After all samples for the study are collected, frozen samples are thawed for batch analysis.
Plasma active renin levels are measured using the active renin enzyme-linked immunosorbent assay kit.
- Conditions
- Sepsis, Obstructive Shock, Critical Illness, Hypotensive, Critically Ill
- Being tested
- Renin levels and lactic acid levels
- Medical subject headings
- Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renin levels and lactic acid levelsDiagnostic test
Sampling of blood for measuring renin and lactate
| Study group | Role | What they receive |
|---|---|---|
| Renin group and lactate group | Renin group and lactate group Receives: Diagnostic Test: Renin levels and lactic acid levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of serum renin level as a marker of tissue perfusion and prediction of mortality of critically ill patients in intensive care unit in comparison with serum lactate.
Number of HYPOTENSIVE CRITICALLY ILL PATIENTS through measurements of the Plasma renin concentrations and Whole blood lactate concentrations at enrollment to intensive care unit (ICU) and at 24, 48, and 72 hours after enrollment
Measured: from baseline to 72 hours after enrollment to intensive care unit (ICU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start21 Jun 2022
- Primary completion25 Jan 2024 (estimated)
- Study completion25 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed A Aboelsuod, MD, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810415
- Sponsor's protocol ID
- 221190
- Status last verified
- Jan 2024
- First submitted
- 21 Jan 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Renin Versus Lactic Acid as Tissue Perfusion Biomarkers for Mortality Prediction in Hypotensive Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05810415
- Acronym / sponsor ID
- 221190
- Conditions
- Sepsis, Obstructive Shock, Critical Illness, Hypotensive, Critically Ill
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 25 Jan 2024 (estimated)
- Study completion
- 25 Jan 2024 (estimated)
- First posted
- 12 Apr 2023 (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.
Measurement of Whole Blood Lactate Concentrations Whole blood lactate concentrations will be measured at the time of study enrollment and at 24, 48, and 72 hours. Measurement of Plasma Renin Concentrations Serum renin concentration will be measured on blood samples drawn from arterial catheters on supine position right after inclusion. Discarded whole blood samples (waste blood samples) in EDTA tubes are prospectively collected from each patient at the time of study enrollment and at 24, 48, and 72 hours.
Detailed description
Elevated renin-levels in critically ill patients are associated with worse outcomes and outperform lactate as a prognostic indicator of survival. Using biomarkers to understand patient trajectory in the ICU has high utility.
Both whole blood lactate concentration and lactate clearance yield meaningful information, but lactate can be an insensitive prognostic marker. Renin has recently emerged as a prognostic marker for ICU mortality.
AIM OF THE WORK Evaluation of serum renin level to determine if it performs well as a marker of tissue-perfusion and prediction of mortality of critically ill patients in intensive care unit in comparison with serum lactate.
a prospective observational study will be conducted.. Patients can be enrolled at any point during their admission. The patients are followed once enrolled and the data are recorded till death or end of ICU stay by dedicated investigator. Primary and secondary outcomes will be analyzed after completing of the study.
Plasma renin concentrations and Whole blood lactate concentrations are measured at enrollment and at 24, 48, and 72 hours.
Measurements
- Patient characteristics: including age, sex, chronic health conditions, weight.
- Reasons of ICU admission.
- length of stay in days (ICU and hospital).
- Mortality (ICU and in-hospital).
- Physiologic data: including heart rate, mean arterial blood pressure (MAP), temperature, respiratory rate, PaO2, FIO2, hematocrit, WBC count, serum creatinine, urine output, blood urea nitrogen, sodium, albumin, bilirubin, glucose, arterial carbon dioxide tension, pH, and the total Glasgow Coma Scale score.
- The need for mechanical ventilation and renal replacement therapy.
- Patient outcome either survivor or not survivor. Measurement of Whole Blood Lactate Concentrations Whole blood lactate concentrations will be measured at the time of study enrollment and at 24, 48, and 72 hours.
Measurement of Plasma Renin Concentrations Serum renin concentration will be measured on blood samples drawn from arterial catheters on supine position right after inclusion.
Discarded whole blood samples (waste blood samples) in EDTA tubes are prospectively collected from each patient at the time of study enrollment and at 24, 48, and 72 hours.
Samples will be centrifuged to yield 2mL of EDTA plasma and then stored at -20°C. After all samples for the study are collected, frozen samples are thawed for batch analysis.
Plasma active renin levels are measured using the active renin enzyme-linked immunosorbent assay kit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renin group and lactate group | – | Diagnostic Test: Renin levels and lactic acid levelsRenin group and lactate group |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study will be conducted at Al-Azhar university hospitals at intensive care unit (ICU). Patients can be enrolled at any point during their admission. The patients are followed once enrolled and the data are recorded till death or end of ICU stay by dedicated investigator
Key inclusion criteria (3 listed)
- Patients aged 21-60 years old
- Those receiving vasopressors for greater than or equal to 6 hours to maintain a mean arterial pressure (MAP) ≥65 mm Hg.
- Anticipated stay >24 hours.
Key exclusion criteria (3 listed)
- Patients or families refusing to participate in the study.
- Patients on renal replacement therapy.
- Patients receiving betablockers
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 |
|---|---|---|
| Renin levels and lactic acid levelsSampling of blood for measuring renin and lactate | Diagnostic test | Renin group and lactate group |
Primary outcome
Evaluation of serum renin level as a marker of tissue perfusion and prediction of mortality of critically ill patients in intensive care unit in comparison with serum lactate.
Time frame: from baseline to 72 hours after enrollment to intensive care unit (ICU)
Number of HYPOTENSIVE CRITICALLY ILL PATIENTS through measurements of the Plasma renin concentrations and Whole blood lactate concentrations at enrollment to intensive care unit (ICU) and at 24, 48, and 72 hours after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
2 sites 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 Obstructive Shock, run by Al-Azhar University at 2 sites 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 3 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 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Abd El-Wahab AS Mohammed, AP (+2(045)33343945, abdelwahabsaleh7020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of serum renin level as a marker of tissue perfusion and prediction of mortality of critically ill patients in intensive care unit in comparison with serum lactate. (time frame: from baseline to 72 hours after enrollment to intensive care unit (ICU)). 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 18 Jan 2024.