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Completed

NCT Number: NCT05327881

Serum Rennin 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 in-hospital mortality in septic shock patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Omar Ali

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. The primary endpoint was 28-day mortality.

    Time frame: 28 days

Secondary outcomes

  1. lactate levels and lactate clearance, plasma renin levels during the first 72 hours, and vasopressor requirements.

    Time frame: baseline, 24, 48, 72 hours

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Serum Renin Kinetics Versus Serum Lactate Kinetics as Predictors of Mortality in Septic Shock Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2022
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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