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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
116
for resuscitation in sepsis patients
for resuscitation in sepsis patients
Chulalongkorn university
Bangkok, Thailand
The incidence of acute kidney injury for any stage and severity
Time frame: at day 7
The neutrophil function (chemotaxis, CD11b ) between two randomized groups at
Time frame: 0, 24, and 72 hours after resuscitation.
The monocyte function (HLA-DR) between two randomized groupsafter resuscitation.
Time frame: at 0, 24, and 72 hours after resuscitation.
The inflammatory marker (IL-6, IL-10) between two randomized groups at
Time frame: 0, 24, and 72 hours after resuscitation.
Urinary neutrophil gelatinase-associated lipocalin (NGAL) after randomization and after resuscitation with trial fluid
Time frame: at 0,24 and 72 hours after resuscitation.
Urinary liver-type fatty acid binding protein (L-FABP)
Time frame: at 0,24 and 72 hours after resuscitation.
Sequential [Sepsis-related] Organ Failure Assessment (SOFA) Score. (excluding Glasgow Coma Score) at 72 hours after randomization.
Time frame: at 72 hours after randomization.
Need of renal replacement therapy within 72 hours after randomization
Time frame: within 72 hours after randomization
Days alive without renal replacement therapy
Time frame: in 28 days after randomization
Hospital length of stay for survivors sanctioned
Time frame: at 28 days after randomization
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