Septic ShockNCT05327881
Serum Rennin Kinetics Versus Serum Lactate Kinetics as Predictors of Mortality in Septic Shock Patients
An observational study of Septic Shock, run by Assiut University at 1 site in Egypt.
Trial summary
Whole blood lactate concentration is widely used in shock states to assess perfusion. We aimed to determine if the change in plasma renin concentration over time would be superior to the change in lactate concentration for predicting 28-day mortality in septic shock patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2025to 30 Jun 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Septic shock patients, septic shock was defined as persistent hypotension (defined as the need for vasopressors to maintain mean arterial pressure ≥ 65 mm Hg, and a serum lactate level > 18 mg/dL [2 mmol/L] despite adequate volume resuscitation
adult patients aged 18 years or older who were diagnosed with septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock.[1] In septic shock, patients' blood lactate levels were found to be more than 2 mmol/L even after receiving enough fluids, and patients' mean arterial pressure (MAP) had to be maintained at 65 mmHg or above with the use of vasopressor medication.Before enrollment, all patients or their authorized representatives were asked to provide written informed consent.
Patients were excluded if they had acute coronary syndrome, chronic treatment with angiotensin receptor blockers (ARBs) or ACE inhibitors (ACEIs), a do-not-resuscitate (DNR) order, chronic kidney disease stage IV or V (baseline estimated glomerular filtration rate <30 mL/min/1.73 m²), or if they passed away within the first 24 hours of being admitted to the intensive care unit (ICU).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Renin Kinetics Versus Serum Lactate Kinetics as Predictors of Mortality in Septic Shock Patients
Whole blood lactate concentration is widely used in shock states to assess perfusion. We aimed to determine if the change in plasma renin concentration over time would be superior to the change in lactate concentration for predicting 28-day mortality in septic shock patients.
Read the detailed description
Resuscitation in the ICU was traditionally based on blood pressure (1, 2). An assumption that adequate tissue perfusion cannot be made at pressures of 65 mm Hg, and the number itself has been challenged in other investigations (1, 3, 4). Lactate has long been regarded as an adequate indicator of tissue perfusion and prognosis. Most critical care resuscitation are guided by serial lactate levels as a mean to understand the flow and perfusion side of resuscitative aims (2, 5). Not all high lactate levels are indicators of poor tissue perfusion (6).In 2017, Khanna et al (7) reinvigorated the interest in the renin-angiotensin-aldosterone system (RAAS) as a significant biochemical hormonal axis and feedback mechanism in vasodilatory shock after they published the results of the Angiotensin II in High Output Shock Trial. Gleeson et al (8) showed in 2018 that renin appeared to be a much stronger and significant predictor of ICU mortality compared with lactate in a heterogenous shock population Jeyaraju et al (9) reported that renin kinetics are superior to lactate kinetics for predicting in-hospital mortality in critically ill patients with hypotension, with most being vasodilatory shock (most common diagnosis sepsis, also vasoplegia, acute respiratory distress syndrome [ARDS], liver failure) and those who had hypotension more than 6 hours while of vasopressors included. The bottom line in the previous investigations is that renin was a better marker of poor outcomes in comparison with concurrently measured lactate levels in critically ill ICU patients.
- Conditions
- Septic Shock
- Being tested
- Plasma renin concentrations will be measured at enrollment and at 24, 48, and 72 hours. Whole blood lactate measurements will be performed according to normal standard of care.
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma renin concentrations will be measured at enrollment and at 24, 48, and 72 hours. Whole blood lactate measurements will be performed according to normal standard of care.Diagnostic test
Arterial blood gas samples, obtained at enrollment and at 24, 48, and 72 hours, were analyzed for lactate concentration using the ABL 800 series analyzer (Radiometer America, Brea, California, USA).
Blood for these measurements was drawn into lithium-heparinized tubes.
Lactate clearance was calculated at 24, 48, and 72 hours according to the following formula:
Lactate Clearance (%) = [(Baseline Lactate - Lactate at Time t) / Baseline Lactate] × 100.
An ELISA kit developed and manufactured by DRG International (Springfield Township, NJ, USA) was used to determine plasma concentrations of active renin. Blood samples were collected in EDTA tubes at baseline and at 24, 48, and 72 hours.. Plasma was separated from centrifuged samples and stored at -80°C for a maximum of 6 months until batch analysis. All samples were analysed in a single batch, and laboratory personnel were blinded to patient outcome. The assay was based on the sandwich ELISA principle
| Study group | Role | What they receive |
|---|---|---|
| Septic shock patients | adult patients aged 18 years or older who were diagnosed with septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock [1]. In septic shock, patients' blood lactate levels were found to be more than 2 mmol/L even after receiving enough fluids, and patients' mean arterial pressure (MAP) had to be maintained at 65 mmHg or above with the use of vasopressor medication Receives: Diagnostic Test: Plasma renin concentrations will be measured at enrollment and at 24, 48, and 72 hours. Whole blood lactate measurements will be performed according to normal standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was 28-day mortality.
Measured: 28 days
Secondary outcomes (1)
lactate levels and lactate clearance, plasma renin levels during the first 72 hours, and vasopressor requirements.
Measured: baseline, 24, 48, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start10 Jan 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Rabiee Ali, Assiut University
- Investigators
- Khaled A. AbdelRahman, Assistant professor, Study chair, Assiut UniversityNagwa M. Ibrahim, Professor, Study chair, Assiut UniversityAbualauon M. Abedalmohsen, Lecturer, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327881
- Sponsor's protocol ID
- ReninvsLactate in septic shock
- Status last verified
- Aug 2026
- First submitted
- 16 Mar 2022
- Last updated
- 23 Sep 2026
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Renin Kinetics Versus Serum Lactate Kinetics as Predictors of Mortality in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT05327881
- Acronym / sponsor ID
- ReninvsLactate in septic shock
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 14 Apr 2022 (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.
Whole blood lactate concentration is widely used in shock states to assess perfusion. We aimed to determine if the change in plasma renin concentration over time would be superior to the change in lactate concentration for predicting 28-day mortality in septic shock patients.
Detailed description
Resuscitation in the ICU was traditionally based on blood pressure (1, 2). An assumption that adequate tissue perfusion cannot be made at pressures of 65 mm Hg, and the number itself has been challenged in other investigations (1, 3, 4). Lactate has long been regarded as an adequate indicator of tissue perfusion and prognosis. Most critical care resuscitation are guided by serial lactate levels as a mean to understand the flow and perfusion side of resuscitative aims (2, 5). Not all high lactate levels are indicators of poor tissue perfusion (6).In 2017, Khanna et al (7) reinvigorated the interest in the renin-angiotensin-aldosterone system (RAAS) as a significant biochemical hormonal axis and feedback mechanism in vasodilatory shock after they published the results of the Angiotensin II in High Output Shock Trial. Gleeson et al (8) showed in 2018 that renin appeared to be a much stronger and significant predictor of ICU mortality compared with lactate in a heterogenous shock population Jeyaraju et al (9) reported that renin kinetics are superior to lactate kinetics for predicting in-hospital mortality in critically ill patients with hypotension, with most being vasodilatory shock (most common diagnosis sepsis, also vasoplegia, acute respiratory distress syndrome [ARDS], liver failure) and those who had hypotension more than 6 hours while of vasopressors included. The bottom line in the previous investigations is that renin was a better marker of poor outcomes in comparison with concurrently measured lactate levels in critically ill ICU patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic shock patients | – | Diagnostic Test: Plasma renin concentrations will be measured at enrollment and at 24, 48, and 72 hours. Whole blood lactate measurements will be performed according to normal standard of care.adult patients aged 18 years or older who were diagnosed with septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock [1]. In septic shock, patients' blood lactate levels were found to be more than 2 mmol/L even after receiving enough fluids, and patients' mean arterial pressure (MAP) had to be maintained at 65 mmHg or above with the use of vasopressor medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Septic shock patients, septic shock was defined as persistent hypotension (defined as the need for vasopressors to maintain mean arterial pressure ≥ 65 mm Hg, and a serum lactate level > 18 mg/dL [2 mmol/L] despite adequate volume resuscitation
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 |
|---|---|---|
| Plasma renin concentrations will be measured at enrollment and at 24, 48, and 72 hours. Whole blood lactate measurements will be performed according to normal standard of care.Arterial blood gas samples, obtained at enrollment and at 24, 48, and 72 hours, were analyzed for lactate concentration using the ABL 800 series analyzer (Radiometer America, Brea, California, USA). Blood for these measurements was drawn into lithium-heparinized tubes. Lactate clearance was calculated at 24, 48, and 72 hours according to the following formula: Lactate Clearance (%) = [(Baseline Lactate - Lactate at Time t) / Baseline Lactate] × 100. An ELISA kit developed and manufactured by DRG International (Springfield Township, NJ, USA) was used to determine plasma concentrations of active renin. Blood samples were collected in EDTA tubes at baseline and at 24, 48, and 72 hours.. Plasma was separated from centrifuged samples and stored at -80°C for a maximum of 6 months until batch analysis. All samples were analysed in a single batch, and laboratory personnel were blinded to patient outcome. The assay was based on the sandwich ELISA principle | Diagnostic test | Septic shock patients |
Primary outcome
The primary endpoint was 28-day mortality.
Time frame: 28 days
1 secondary outcome
lactate levels and lactate clearance, plasma renin levels during the first 72 hours, and vasopressor requirements.
Time frame: baseline, 24, 48, 72 hours
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 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Sepsis
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.
Khaled A. AbdelRahman, Assistant professor study chair
Assiut University
Nagwa M. Ibrahim, Professor study chair
Assiut University
Abualauon M. Abedalmohsen, Lecturer study chair
Assiut 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 Septic Shock, run by Assiut 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?
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 23 Sep 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 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?
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?
The primary endpoint was 28-day mortality. (time frame: 28 days). 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 23 Sep 2026.