| Bias | Author's judgement | Support for judgement |
| Randomization |
High |
Quote: "Each ICU was assigned with an independent random numeric table generated by Microsoft Excel 2019 by the primary investigator alone. Each table had equal numbers of 1 and 2, which represented the placebo group (bacteriostatic water infusion) and treatment group (HDIVC), respectively. Participants were enrolled in the corresponding group in an orderly manner." Comment: Allocation sequence random. The allocation was probably not concealed. |
| Deviations from intervention |
Low |
Registry quote: "Masking: Triple (Participant, Care Provider, Outcomes Assessor)"
Comment: Blinded study. Participants were analyzed according to their assigned intervention. |
| Missing outcome data |
Low |
Quote: "Two
patients (one in the HDIVC group and one in the placebo group) were excluded due to the treatment
period of less than three days due to death."
Comment: 56 randomized, 54 analyzed. All missing data occurred due to documented reasons related to the outcome, Mortality. However data is available for >95% of population. Risk assessed to be low for outcomes: Mortality. Time to death. Incidence of clinical improvement. Adverse events. |
| Measurement of the outcome |
Low |
Comment: Appropriate method of outcome measurement.
Measurement of outcome does not differ between groups. Blinded study (outcome assessors unaware of intervention assignment). Risk assessed to be low for outcomes: Mortality. Time to death. Incidence of clinical improvement. Adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The protocol and statistical analysis plan were not available.
Risk assessed to be some concerns for the outcomes: Mortality. Time to death. Incidence of clinical improvement. Adverse events. |
| Overall risk of bias |
High |