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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05810415
• Other study ID #: 221190
• Status: Recruiting
• Start date: June 21, 2022
• Est. completion date: January 25, 2024

Study information

• Verified date: January 2024
• Source: Azhar University
• Contact: Abd El-Wahab AS Mohammed, AP
• Phone: +2(045)33343945
• Email: abdelwahabsaleh7020[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Hypotension
• Hypotensive
• Sepsis

Intervention

Diagnostic Test:
• Renin levels and lactic acid levels
Sampling of blood for measuring renin and lactate

Locations

Country	Name	City	State
Egypt	Azhar unversity	Cairo
Egypt	Azhar University	Madinat An Nasr	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)