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

NCT05810415 | Unknown

• 1 other identifier: 221190
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Renin group and lactate group

Renin group and lactate group

Diagnostic Test: Renin levels and lactic acid levels

Interventions

Renin levels and lactic acid levels DIAGNOSTIC_TEST

Sampling of blood for measuring renin and lactate

Renin group and lactate group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (2)

Azhar University

Madīnat an Naşr, Cairo Governorate, 11765, Egypt

RECRUITING

Azhar unversity

Cairo, Egypt

COMPLETED

MeSH Terms

Conditions

Sepsis; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Central Study Contacts

Abd El-Wahab AS Mohammed, AP

CONTACT

+2(045)33343945; abdelwahabsaleh7020@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anesthesia intensive care and pain management

Study Record Dates

• First Submitted: January 21, 2023
• First Posted: April 12, 2023
• Study Start: June 21, 2022
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

EG (2)