Summary of findings 3. Intravenous immunoglobulin compared to placebo for NSTI.
| Intravenous immunoglobulin compared to placebo for NSTI | ||||||
| Patient or population: NSTI Setting: intensive care unit Intervention: intravenous immunoglobulin Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality/Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with Intravenous immunoglobulin | |||||
| Mortality follow‐up: 30 days | Study population | RR 1.17 (0.42 to 3.23) | 100 (1 RCT) | ⊕⊕⊝⊝ Lowa | — | |
| 0 per 100 | 0 per 100 (0 to 0) | |||||
| Moderate | ||||||
| 23 per* 100 | 21 per 100 (8 to 58) | |||||
| Serious adverse events (SAE) follow‐up: unclear | Study population | RR 0.73 (0.32 to 1.65) | 100 (1 RCT) | ⊕⊕⊝⊝ Lowa | Serious adverse reactions included acute kidney injury, allergic reactions, aseptic meningitis syndrome, haemolytic anaemia, thrombi, and transmissible agents | |
| 22 per 100 | 16 per 100 (7 to 36) | |||||
| Survival time | — | — | — | 100 (1 RCT) | ⊕⊕⊝⊝ Lowa | The median time of death was shorter in the IVIG group than in the placebo group (25 days versus 49 days) (not possible to calculate hazard ratio with the data provided) |
| Assessment of long‐term morbidity | — | — | — | — | — | Not reported |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Assumed risk for mortality was based on data of the literature (Audureau 2017; May 2009). For serious adverse effects it was based on the results of the trial. CI: Confidence interval; RR: Risk ratio | ||||||
| GRADE Working Group grades of evidence High quality/certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality/certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality/certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality/certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
aDowngraded by two levels: one level for high risk of attrition bias (38% lost of follow‐up); other bias: imbalance at baseline for one dose 25 IVIG received before randomisation (40% in placebo group vs 16% IVIG group). One level for indirectness as a minority of patients have an infection linked to bacteria producing toxins