Study | Reason for exclusion |
---|---|
Battison 2005 | This is a prospective, cross‐over, pilot trial. |
Bourdeaux 2011 | Participants received doses of HTS or sodium bicarbonate in a random order, some having both. This may result in cross‐over effects between treatments. |
Du 2017 | This trial was excluded because there was no defined trigger for starting hyperosmotherapy to reduce ICP, and mannitol was administered every eight hours. |
Hong 2017 | This trial was excluded due to unreliable methods (HTS or other ICP‐lowering agents were administered by time but not according to ICP monitoring). |
Huang 2014 | This is a randomised clinical trial with a cross‐over design. |
Huang 2015 | This trial was excluded for questionable sequence generation; there was no reporting on outcomes of interest to this review. |
Ichai 2009 | Sodium lactate was used to decrease the raised ICP. Sodium lactate differs fundamentally from sodium chloride; infusion of sodium lactate in TBI decreases the occurrence of raised ICP. The absence of significant modification of plasma osmolarity does not support a pure osmotic effect of sodium lactate. |
Jafari 2018 | This trial was excluded because it assessed the effects of adding furosemide to 1 of 2 groups both receiving HTS. |
Jiang 2018 | RCT. Excluded because of ineligible comparator (there were 3 arms, all of HTS, in the same concentration but delivered at different speeds (6 mL/3 mL/2 mL per h). |
Jin 2018 | Excluded due to doubts about sequence generation and apparently unreliable data. We were unable to contact trial authors for clarification. |
Li 2018 | Excluded due to unreliable data and methods (there is an error in the judgement of P value). |
Liang 2013 | Excluded due to unreliable data and methods (incorrect 'T' values, questionable sequence generation). We were unable to contact trial authors for clarification. |
Liu 2018 | Excluded due to unreliable methods (HTS or other ICP‐lowering agents were administered by time but not according to ICP monitoring). |
Mei 2016 | Excluded due to unreliable data and methods (incorrect 'T' values, questionable sequence generation). We were unable to contact trial authors for clarification. |
NCT01028339 | Appeared to meet inclusion criteria but according to the clinicaltrials.gov record it has been "terminated. (No patients enrolled during 2 years)". |
NCT01108744 | This trial met inclusion criteria but according to the clinicaltrials.gov record was "...withdrawn prior to enrolment. Timeline to consent prior to intervention start was unfeasible". |
NCT01111682 | This trial met inclusion criteria but according to the clinicaltrials.gov record was "...terminated. (A significant reduction in head injuries coupled with more frequent use of craniectomy reduced the number of potential subjects)". |
NCT01215019 | This trial met inclusion criteria but according to the clinicaltrials.gov record was "...withdrawn prior to enrolment. (Lack of funding; no subjects enrolled)". |
Ni 2018 | Excluded due to unreliable data and methods (e.g. no clear definition of ICP). |
Polushin 2009 | This is a randomised clinical trial with a cross‐over design. |
Roquilly 2017 | This planned RCT is measuring continuous hyperosomolar therapy (HTS) in participants with TBI vs standard care (which is unlikely to include other ICP‐lowering agents). |
Sakellaridis 2011 | This is a prospective, cross‐over, pilot trial. |
Shu 2015 | Excluded due to unreliable data and methods (incorrect 'T' values, questionable sequence generation). We were unable to contact trial authors for clarification. |
Upadhyay 2010 | The sequence generation was described (quasi‐randomisation). The included participants were 200 children with increased ICP of various different aetiologies, of whom only 14 had TBI. Comparison of average reduction of MAP at defined intervals was performed to indirectly assess reduction in ICP. |
Wang 2017 | This trial was non‐therapeutic in nature, measuring only coagulation. |
Yang 2019 | This trial was excluded because it compared two different doses of HTS (7.5% HTS (4 ml/kg) and 3% HS treatment (4 ml/kg)). |
Zhang 2014 | Excluded due to unreliable data and methods (incorrect 'T' values, questionable sequence generation). We were unable to contact trial authors for clarification. |
Zhang 2015 | Excluded due to unreliable data and methods (incorrect 'T' values, questionable sequence generation). We were unable to contact trial authors for clarification. |
Zhang 2018 | Excluded due to unreliable methods (HTS or other ICP‐lowering agents were administered by time, but not according to results of ICP monitoring). |
HTS: hypertonic saline; ICP: intracranial pressure; MAP: mean arterial pressure; RCT: randomised controlled trial; TBI: traumatic brain injury;