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Use of Renin Versus Lactic Acid as Tissue Perfusion Biomarkers for Mortality Prediction in Hypotensive Critically Ill Patients

Use of Renin Versus Lactic Acid as Tissue Perfusion Biomarkers for Mortality Prediction in Hypotensive Critically Ill Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05810415
Enrollment
84
Registered
2023-04-12
Start date
2022-06-21
Completion date
2024-01-25
Last updated
2024-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Critically Ill, Hypotensive, Obstructive Shock, Sepsis

Brief 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 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 1. Patient characteristics: including age, sex, chronic health conditions, weight. 2. Reasons of ICU admission. 3. length of stay in days (ICU and hospital). 4. Mortality (ICU and in-hospital). 5. 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. 6. The need for mechanical ventilation and renal replacement therapy. 7. 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.

Interventions

DIAGNOSTIC_TESTRenin levels and lactic acid levels

Sampling of blood for measuring renin and lactate

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Patients aged 21-60 years old 2. Those receiving vasopressors for greater than or equal to 6 hours to maintain a mean arterial pressure (MAP) ≥65 mm Hg. 3. Anticipated stay \>24 hours.

Exclusion criteria

1. Patients or families refusing to participate in the study. 2. Patients on renal replacement therapy. 3. Patients receiving betablockers

Design outcomes

Primary

MeasureTime frameDescription
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.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

Countries

Egypt

Contacts

Primary ContactAbd El-Wahab AS Mohammed, AP
abdelwahabsaleh7020@gmail.com+2(045)33343945

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026