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

NCT05327881 | Unknown

• 1 other identifier: ReninvsLactate in septic shock
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 28 days mortality

  28 days

Study Arms (1)

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.

Interventions

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. DIAGNOSTIC_TEST

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)

Septic shock patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• chronic kidney disease stage IV/V (baseline eGFR (estimated glomerular filtration rate) \<30ml/min/1.73m2),
• do not resuscitate order.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Khaled A. AbdelRahman, Assistant professor

  Assiut University

  STUDY CHAIR

• Nagwa M. Ibrahim, Professor

  Assiut University

  STUDY CHAIR

• Abualauon M. Abedalmohsen, Lecturer

  Assiut University

  STUDY CHAIR

Central Study Contacts

Omar Rabiee, masters degree

CONTACT

01092834334; omarrabiee@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer, Anesthesia and ICU department, Faculty of medicine, Assiut University

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 14, 2022
• Study Start: June 30, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 14, 2022

Record last verified: 2022-04