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Table 2 Summary of the key interventional clinical studies that have compare 0.9 % saline to buffered crystalloid fluid in adult patients

From: Crystalloid fluid therapy

  Design, setting and participants Key Findings
Acutely unwell population
The SPLIT trial. 2015 [27] Multicentre, double-blind, cluster randomised, double crossover trial comparing 0.9 % saline with Plasma-Lyte 148®; n= 2262 • There was no significant difference between group in rates of AKI or AKI requiring RRT
• There was no significant difference between groups in survival to day 90
Smith et al. 2015 [28] Single centre, double-blind RCT comparing 0.9 % saline with Plasma-Lyte A® in critically ill trauma patients; n=18 • Patients receiving 0.9 % saline had significantly lower serum chloride and bicarbonate concentration
• Patients receiving Plasma-Lyte A® had a quicker fibrin build up and cross linking (α angle) at 6 hours after infusion
• No difference between groups in coagulation tests or blood products received at 6 hours
Young et al. 2014 [29] Single centre, double-blind RCT comparing 0.9 % saline with Plasma-Lyte A® in patient presenting to ED with severe acute trauma; n=46 • Patients receiving 0.9 % saline had an increase in serum chloride concentration and decrease in serum pH
• No significant differences in mortality hospital length of stay, blood transfusion requirements or utilization of resources
Cieza et al. 2013 [30] Single centre, open label RCT comparing 0.9 % saline with Ringer’s lactate in patients with severe dehydration secondary to choleriform diarrhea; n=40 • Patients receiving 0.9 % saline had lower serum pH at 2 and 4 hours
• No difference between in serum creatinine, lactate or potassium concentration
Hasman et al. 2012 [31] Single centre, double-blind RCT comparing either 0.9 % saline, Ringer's lactate or Plasma-Lyte® in patients presenting to ED with dehydration; n= 90 • Patients receiving 0.9 % saline had a significantly lower serum pH and lower serum bicarbonate concentration
• No difference between groups in chloride, potassium, or sodium concentrations
Van Zyl et al. 2012 [32] Multicentre, double-blind RCT of Ringer’s lactate versus 0.9 % saline in patients presenting to ED with diabetic ketoacidosis; n=54 • There was no significant difference between groups in time interval for correction of acidosis
• Patient receiving 0.9 % saline a significantly shorter time to lower blood glucose
• No difference between groups in hospital length of stay
Mahler et al. 2011 [33] Single centre, double-blind RCT comparing either 0.9 % saline with Plasma-Lyte A® in patients presenting to ED with diabetic ketoacidosis; n= 45 • Patients receiving 0.9 % saline had significantly higher serum chloride and lower bicarbonate concentration
Wu et al. 2011 [34] Multicentre, open label RCT comparing 0.9 % saline with Ringer’s lactate in patients diagnosed with acute pancreatitis; n=40 • Patients receiving Ringer’s lactate had lower rates of SIRS and lower CRP concentration at 24 hours
• No difference between groups in development of complications or hospital length of stay
Cho et al. 2007 [35] Multicentre, single-blind RCT of Ringer’s lactate versus 0.9 % saline in patients presenting to ED with rhabdomyolysis; n=28 • Patients receiving 0.9 % saline had a significantly higher serum chloride and sodium concentration and lower serum pH
• There was no significant difference between groups in time interval for normalisation of creatine kinase
Surgical population
The SPLIT- Major Surgery trial. 2015 Prospective phase 4, single centre blinded study investigating the safety and efficacy of using 0.9 % saline with Plasma-Lyte® 148 as fluid therapy in adult patients undergoing major surgery; n=1100 • There was no significant difference between groups in rates of AKI
• There were no significant difference between groups in the development of postoperative complications or length of hospital stay
• Patients who received 0.9 % saline developed a transient hyperchloremic metabolic acidosis on postoperative day 1
Potura et al. 2015 [36] Single centre, open label RCT comparing 0.9 % saline with Elomel Isoton®(low chloride, acetate buffered crystalloid) in patients undergoing renal transplantation; n=150 • Significantly more patients receiving 0.9 % saline required intra-operative inotrope support
• Patients receiving 0.9 % saline had a significantly lower base excess and higher serum chloride concentration
• No difference between groups in post-operative urine output, creatinine, blood urea nitrogen or need for RRT
Song et al. 2015 [37] Single centre, open label RCT comparing 0.9 % saline with Plasma-Lyte® in patients undergoing spinal surgery; n=50 • Patients receiving 0.9 % saline had lower pH, base excess, and bicarbonate concentration and higher serum chloride concentration
• Patients receiving Plasma-Lyte® had significantly higher urine output
• No difference between groups in rotation thromboelastometry analysis, estimated blood loss or transfusion requirements
Hafizah et al. 2015 [38] Single centre, open label RCT comparing 0.9 % saline with Sterofundin® ISO patients undergoing neurosurgery (low chloride, acetate buffered crystalloid); n=30 • Patients receiving 0.9 % saline had a significantly lower serum pH and higher serum chloride and sodium concentration
Kim et al. 2013 [39] Single centre, blinded RCT comparing either 0.9 % saline with Plasma-Lyte® in patients undergoing renal transplantation; n= 60 • Patients receiving 0.9 % saline had lower pH and base excess values
• No difference between groups in post-operative urine output, creatinine or need for RRT
Modi et al. 2012 [40] Single centre, double-blind RCT comparing 0.9 % saline with Ringer's lactate in patients undergoing renal transplantation; n= 74 • Patients receiving 0.9 % saline had lower serum pH and base excess values
• No difference between groups in post-operative urine output or creatinine
Heidari et al. 2011 [41] Single centre, double-blind RCT comparing 0.9 % saline with Ringer’s lactate and 5% saline in patients undergoing lower abdominal surgery; n=90 • A higher proportion of patients that had received 0.9 % saline had experienced vomiting 6 hours post-operatively
Hadimioglu et al. 2008 [42] Single centre, double-blind RCT comparing either 0.9 % saline, Ringer's lactate or Plasma-Lyte® in patients undergoing renal transplantation; n= 90 • Patients receiving 0.9 % saline had an increase in serum chloride concentration and decrease in serum pH
• Patients receiving Ringer’s lactate had a significantly increased serum lactate concentration
• There was no significant difference between in postoperative creatinine or need for RRT
Khajavi et al. 2008 [43] Single centre, double-blind RCT comparing 0.9 % saline with Ringer's lactate in patients undergoing renal transplantation; n= 52 • Patient receiving 0.9 % saline had a significantly lower serum pH and higher serum potassium concentration at the end of the operation
Chin et al. 2006 [44] Single centre, open label RCT comparing 0.9 % saline with Ringer’s lactate, 0.9 % saline with dextrose 5 % in non-diabetic patients undergoing elective surgery; n=50 • No difference between groups in serum urea, sodium or potassium concentration
• Dextrose 5 % resulted in significant, albeit transient hyperglycemia, even in non-diabetic patients
Karaca et al. 2006 [45] Single centre, single-blinded RCT comparing 0.9 % saline with Ringer’s lactate and 4 % gelatin polysuccinate in patients undergoing transurethral prostatectomy under spinal anesthesia; n=60 • No difference between groups nausea, vomiting, dizziness and post spinal hearing loss.
Chanimov et al. 2006 [46] Single centre, double-blinded RCT comparing 0.9 % saline with Ringer’s lactate in patients undergoing Cesarean section; n=40 • No difference between groups in inotrope requirements
• No significant differences in the Apgar scores at 1 and 5 min or infant well-being
O’Malley et al. 2005 [47] Single centre, double blind RCT comparing 0.9 % saline with Ringer’s lactate in patients undergoing renal transplantation; n=51 • Significantly more patients receiving 0.9 % saline required intra-operative treatment for metabolic acidosis and hyperkalemia
• No difference between groups in post-operative urine output, creatinine or need for RRT
Takil et al. 2002 [48] Single centre, open label RCT comparing 0.9 % saline with Ringer’s lactate in patients undergoing spinal surgery; n=30 • Patients receiving 0.9 % saline had an increase in serum chloride, sodium concentration and decrease in serum pH
• No difference between groups in intraoperative hemodynamic variables or hospital and ICU lengths of stay
Waters et al. 2001 [49] Single centre, double-blind RCT comparing 0.9 % saline with Ringer’s lactate in patients undergoing abdominal aortic aneurysm surgery; n=66 • Patients receiving 0.9 % saline had an increase in serum chloride, sodium concentration and decrease in serum pH
• Patients receiving 0.9 % saline received a greater volume of platelets
• No difference between groups in estimated blood loss, postoperative complications, hospital and ICU lengths of stay
Scheingraber et al. 1999 [50] Single centre, open label RCT comparing 0.9 % saline with Ringer’s lactate in patients undergoing gynecologic surgery; n=24 • Patients receiving 0.9 % saline had an increase in serum chloride concentration and decrease in serum pH
Ramanathan et al. 1984 [551] Single centre, open label RCT comparing 0.9 % saline with Ringer’s lactate, Ringer’s lactate with dextrose 5 % and Plasma-Lyte A® in patients undergoing Cesarean section; n=60 • Patients receiving 0.9 % saline had an decrease in serum pH
• No difference between groups in blood pressure or inotrope requirements
  1. AKI acute kidney injury, CRP C-reactive protein, ED emergency department, RCT randomized control trial, RRT renal replacement therapy, SIRS systemic inflammatory response syndrome, The SPLIT trial 0.9 % Saline versus Plasma-Lyte 148® for Intensive Care Unit fluid Therapy trial, The SPLIT- Major Surgery trial 0.9 % Saline or Plasma-Lyte® 148 as fluid therapy in adult patients undergoing major surgery trial