Acute Kidney Injury, Sepsis, Septic Shock
Conditions
Brief summary
The high chloride content of 0.9%sodium chloride (0.9%NaCl) leads to adverse pathophysiological effects in both animals and healthy human volunteers. Small randomized trials confirm that the hyperchloremic acidosis induced by 0.9%NaCl also occurs in patients. A strong signal is emerging from recent large propensity-matched and cohort studies for the adverse effects that 0.9% NaCl has on the clinical outcome in surgical and critically ill patients when compared with balanced crystalloids. Major complications are the increased incidences of acute kidney injury and the need for renal replacement therapy, and that pathological hyperchloremia may increase postoperative mortality. Fluid resuscitation with 0.9% NaCl in animals with sepsis resulted in hyperchloremic metabolic acidosis, worsened AKI, and increased mortality when compared with resuscitation with a balanced crystalloid solution. Furthermore, hyperchloremic acidosis also resulted in increased concentrations of circulating inflammatory mediators in an experimental model of severe sepsis in rats, with a dose-dependent increase in circulating interleukin-6, tumor necrosis factor-a, and interleukin-10 concentrations with increasing acidosis. Thus, in this study, investigators compared the effects of a balanced crystalloid solution with 0.9% NaCl on the renal function in severe sepsis/septic shock patients. Investigators hypothesized that balanced crystalloid solution resuscitation would decrease AKI incidence and severity and would improve immunomodulatory effect when compared with 0.9% NaCl resuscitation.
Interventions
DRUGNormal saline
for resuscitation in sepsis patients
DRUGRinger's Acetate
for resuscitation in sepsis patients
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Who need fluid resuscitation in the Emergency Room (ER). * Who have fulfilled the criteria for sepsis/septic shock within the previous 24 hours according to sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. o Patients with infection and resulted from a host's systemic inflammatory response syndrome (SIRS) to infection are defined as sepsis if meet the criteria 2 or more of * Temperature \>38°C or \<36°C * Heart rate \>90/min * Respiratory rate \>20/min or PaCo2 \<32 mm Hg (4.3 kPa) * White blood cell count \>12000/mm3 or \<4000/mm3 or \>10% immature bands. * Patient who have Septic shock is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality. o Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level \>2 mmol/L (18 mg/dL) despite adequate volume resuscitation. * AND where informed consent is obtainable either from the patient or by proxy (first degree relative, spouse) if patients aren't in fully conscious status (eg.comatose, drowsiness, irritable).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of acute kidney injury for any stage and severity | at day 7 |
Secondary
| Measure | Time frame |
|---|---|
| The monocyte function (HLA-DR) between two randomized groupsafter resuscitation. | at 0, 24, and 72 hours after resuscitation. |
| The inflammatory marker (IL-6, IL-10) between two randomized groups at | 0, 24, and 72 hours after resuscitation. |
| Urinary neutrophil gelatinase-associated lipocalin (NGAL) after randomization and after resuscitation with trial fluid | at 0,24 and 72 hours after resuscitation. |
| Urinary liver-type fatty acid binding protein (L-FABP) | at 0,24 and 72 hours after resuscitation. |
| The neutrophil function (chemotaxis, CD11b ) between two randomized groups at | 0, 24, and 72 hours after resuscitation. |
| Need of renal replacement therapy within 72 hours after randomization | within 72 hours after randomization |
| Days alive without renal replacement therapy | in 28 days after randomization |
| Hospital length of stay for survivors sanctioned | at 28 days after randomization |
| Sequential [Sepsis-related] Organ Failure Assessment (SOFA) Score. (excluding Glasgow Coma Score) at 72 hours after randomization. | at 72 hours after randomization. |
Countries
Thailand
Outcome results
None listed