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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05327881

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Septic Shock	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.

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 30, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Septic shock patients Adult patients on vasopressors for greater than 6 hours to maintain a mean arterial pressure greater than or equal to 65 mm Hg. Inclusion criteria: age over 18, urinary catheter in situ, anticipated stay >24 hours, and signed informed consent by patient or next-of-kin. 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	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)

Arm

Intervention/Treatment

Septic shock patients

Adult patients on vasopressors for greater than 6 hours to maintain a mean arterial pressure greater than or equal to 65 mm Hg. Inclusion criteria: age over 18, urinary catheter in situ, anticipated stay >24 hours, and signed informed consent by patient or next-of-kin. 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

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)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

28 days mortality [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Study Chair: Khaled A. AbdelRahman, Assistant professor, Assiut University
Study Chair: Nagwa M. Ibrahim, Professor, Assiut University
Study Chair: Abualauon M. Abedalmohsen, Lecturer, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Omar Rabiee Ali, Assistant Lecturer, Anesthesia and ICU department, Faculty of medicine, Assiut University, Assiut University

ClinicalTrials.gov Identifier:

NCT05327881

Other Study ID Numbers:

ReninvsLactate in septic shock

First Posted:

Apr 14, 2022

Last Update Posted:

Apr 14, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Shock, Septic

Shock

Study Results

No Results Posted as of Apr 14, 2022