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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Critical Illness; Critically Ill; Hypotensive; Obstructive Shock
• Intervention / Treatment: Diagnostic test: Renin levels and lactic acid levels

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.

• Study Type: Observational
• Enrollment (Estimated): 84

Contacts and Locations

• Study Contact: Name: Abd El-Wahab AS Mohammed, AP; Phone Number: +2(045)33343945; Email: abdelwahabsaleh7020@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Completed
    • Azhar unversity
  • Cairo
    • Madīnat An Naşr, Cairo, Egypt, 11765
      • Recruiting
      • Azhar University
      • Contact: Abd El-Wahab AS Mohammed, AP; Email: abdelwahabsaleh7020@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study will be conducted at Al-Azhar university hospitals at intensive care unit (ICU). 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Renin group and lactate group	Diagnostic test: Renin levels and lactic acid levels; 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.	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: Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Estimated): January 25, 2024
• Study Completion (Estimated): January 25, 2024

Study Registration Dates

• First Submitted: January 21, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Critical Illness; Hypotension
• Other Study ID Numbers: 221190

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