Use of Renin Versus Lactic Acid as Tissue Perfusion Biomarkers for Mortality Prediction in Hypotensive Critically Ill Patients
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Abd El-Wahab AS Mohammed, AP
- Phone Number: +2(045)33343945
- Email: abdelwahabsaleh7020@gmail.com
Study Locations
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Cairo, Egypt
- Completed
- Azhar unversity
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Cairo
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Madīnat An Naşr, Cairo, Egypt, 11765
- Recruiting
- Azhar University
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Contact:
- Abd El-Wahab AS Mohammed, AP
- Email: abdelwahabsaleh7020@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients or families refusing to participate in the study.
- Patients on renal replacement therapy.
- Patients receiving betablockers
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Renin group and lactate group
|
Sampling of blood for measuring renin and lactate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
from baseline to 72 hours after enrollment to intensive care unit (ICU)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 221190
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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