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

August 20, 2026 updated by: Omar Rabiee Ali, Assiut University

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 in-hospital mortality in septic shock patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Asyut, Egypt, 71515
        • Omar Ali

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint was 28-day mortality.
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
lactate levels and lactate clearance, plasma renin levels during the first 72 hours, and vasopressor requirements.
Time Frame: baseline, 24, 48, 72 hours
baseline, 24, 48, 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Khaled A. AbdelRahman, Assistant professor, Assiut University
  • Study Chair: Nagwa M. Ibrahim, Professor, Assiut University
  • Study Chair: Abualauon M. Abedalmohsen, Lecturer, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ReninvsLactate in septic shock

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe