| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
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. The generated random
list was stored by the principal investigator who was not involved in the treatment of patients and hidden
to the other investigators. When a patient was transferred to the ICU and met the enrolment criteria, the
clinician on duty would inform the principal investigator and obtain a number from the list. Then,
participants were enrolled in the corresponding group according to the chronological order of ICU
recruitment. The grouping and intervention were unknown to the participants and investigators who were
responsible for data collection and statistical analysis" Comment: randomization process described, Allocation sequence random and probably 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. |
| 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. |
| Selection of the reported results |
Low |
Comment: The protocol and statistical analysis plan were not available. The prospective registry was available.
Result was not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality. Time to death. |
| Overall risk of bias |
Low |