Table 6
Author, date and countryPatient groupStudy type (level of evidence)Key resultsOutcomesStudy weaknesses
Wade CE et al, 1997, Sweden223 patients with severe head injuries and hypotension. 250 ml 7.5% NaCl/6% Dextran 70 (single bolus) v standard care (usually Ringer’s lactate)Cohort analysis from six previous PRCTs24 hour survivalOdds ratio of 1.92 (p = 0.06) for survival 24 hours with HSHeterogeneous trials, which were not all designed to assess head injured patients
Discharge SurvivalOdds ratio of 2.12 (p = 0.048) for survival until discharge with HSLong term outcome not assessed
Shackford SR et al, 1998, USA34 patients with severe head injuries and undergoing ICP monitoring. 1.6% NaCl (HS) v Ringer’s lactate (RL) to treat “episodes of haemodynamic instability” during initial resuscitation and for 5 daysPRCTICPNo significant difference between groups. Maximum ICP fell 9.1 mm Hg with HS and rose 2.5 mm Hg with RL (p<0.05)CPP not addressed
Number of interventions to control increased ICPAverage of 31 interventions per patient with HS v 11 interventions with RL (p<0.01)HS group had more severe injuries
Glasgow Outcome Score at dischargeNo significant differenceSmall numbers: a power study indicated the need for 320 patients but only 34 were enrolled
Simma B et al, 1998, Switzerland32 children with severe head injury and ICP monitoring. 1.6% NaCl (HS) v Ringer’s lactate (RL) as only IV fluid for 3 days following injury.PRCTICP and CPP Number of interventions to control increased ICPNo significant difference Average of 44 interventions per patient with HS v 62 per patient with RL. (p<0.02)Small numbers: the power calculation was directed towards detecting a difference in ICP
Na concentration and ICPInverse correlation (p<0.3) in both groups
Na concentration and CPPInverse correlation significant only in HS group after 8 hours (p = 0.002) otherwise N/S
Length of ICU stayShorter ICU stay: 11.6 v 8.0 days (p = 0.04)Increase in ICP treated by stepwise increase therapy, thus not surprising that no difference in ICP seen
ComplicationsHigher incidence in RL group (N/S)
Ventilation timesLonger duration in RL group (N/S)
Length of hospital stayNo significant difference
SurvivalNo significant difference