Serum Rennin Kinetics Versus Serum Lactate Kinetics as Predictors of Mortality in Septic Shock Patients

Septic Shock Clinical Trial

Official title:

Serum Rennin Kinetics Versus Serum Lactate Kinetics as Predictors of Mortality in Septic Shock Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05327881
• Other study ID #: ReninvsLactate in septic shock
• Status: Not yet recruiting
• Start date: June 30, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2022
• Source: Assiut University
• Contact: Omar Rabiee, masters degree
• Phone: 01092834334
• Email: omarrabiee[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Whole blood lactate concentration is widely used in shock states to assess perfusion. We aimed to determine if the change in plasma renin concentration over time would be superior to the change in lactate concentration for predicting in-hospital mortality in septic shock patients.

Description:

Resuscitation in the ICU was traditionally based on blood pressure (1, 2). An assumption that adequate tissue perfusion cannot be made at pressures of 65 mm Hg, and the number itself has been challenged in other investigations (1, 3, 4). Lactate has long been regarded as an adequate indicator of tissue perfusion and prognosis. Most critical care resuscitation are guided by serial lactate levels as a mean to understand the flow and perfusion side of resuscitative aims (2, 5). Not all high lactate levels are indicators of poor tissue perfusion (6).In 2017, Khanna et al (7) reinvigorated the interest in the renin-angiotensin-aldosterone system (RAAS) as a significant biochemical hormonal axis and feedback mechanism in vasodilatory shock after they published the results of the Angiotensin II in High Output Shock Trial. Gleeson et al (8) showed in 2018 that renin appeared to be a much stronger and significant predictor of ICU mortality compared with lactate in a heterogenous shock population Jeyaraju et al (9) reported that renin kinetics are superior to lactate kinetics for predicting in-hospital mortality in critically ill patients with hypotension, with most being vasodilatory shock (most common diagnosis sepsis, also vasoplegia, acute respiratory distress syndrome [ARDS], liver failure) and those who had hypotension more than 6 hours while of vasopressors included. The bottom line in the previous investigations is that renin was a better marker of poor outcomes in comparison with concurrently measured lactate levels in critically ill ICU patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age over 18

• anticipated stay >24 hours

• signed informed consent by patient or next-of-kin.

• Septic shock patients, septic shock was defined as persistent hypotension (defined as the need for vasopressors to maintain mean arterial pressure = 65 mm Hg, and a serum lactate level > 18 mg/dL [2 mmol/L] despite adequate volume resuscitation

Exclusion Criteria:

• chronic kidney disease stage IV/V (baseline eGFR (estimated glomerular filtration rate) <30ml/min/1.73m2),

• do not resuscitate order.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Diagnostic Test:
• Plasma renin concentrations will be measured at enrollment and at 24, 48, and 72 hours. Whole blood lactate measurements will be performed according to normal standard of care.
Measurement of Whole Blood Lactate Concentrations: Whole blood lactate concentrations were measured using ABL 800 series analyzers. The IRB (Institutional Review Board) protocol specified that lactate concentrations could be obtained as part of routine care, but lactate concentrations were not measured independently for research purposes. Measurement of Plasma Renin Concentrations: Discarded whole blood samples (waste blood samples) in EDTA (ethylenediaminetetraacetic acid) (BD Vacutainer, 4 mL) tubes were prospectively collected from each patient at the time of study enrollment and at 24, 48, and 72 hours. Plasma active renin levels were measured using the active renin enzyme-linked immunosorbent assay kit (DRG International, Township, NJ)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Plasma renin levels at enrollment and after 24, 48, and 72 hours in septic shock patients		At enrollment and after 24, 48, and 72 hours.
Secondary	28 days mortality		28 days