Clinical trial NCT05327881: Serum Rennin Kinetics Versus Serum Lactate Kinetics as Predictors of Mortality in Septic Shock Patients
Official title: Serum Rennin Kinetics Versus Serum Lactate Kinetics as Predictors of Mortality in Septic Shock Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Plasma renin levels at enrollment and after 24, 48, and 72 hours in septic shock patients
timeFrame: At enrollment and after 24, 48, and 72 hours.
Secondary outcomes:
measure: 28 days mortality
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Khaled A. AbdelRahman, Assistant professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Nagwa M. Ibrahim, Professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Abualauon M. Abedalmohsen, Lecturer
role: STUDY_CHAIR
References: