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Table 1 Primary, secondary and exploratory outcomes for the FFAKI trial

From: Forced fluid removal versus usual care in intensive care patients with high-risk acute kidney injury and severe fluid overload (FFAKI): study protocol for a randomised controlled pilot trial

Primary outcome

Cumulative fluid balance 5 days after randomisation

Secondary outcomes

Mean daily fluid balance during ICU stay

Cumulative fluid balance during the entire ICU stay

Time to neutral cumulative fluid balance

Number of patients with one or more major protocol violations

Accumulated SARs in each intervention arm during the ICU stay

Exploratory outcomes

All-cause mortality at day 90

Days alive and out of hospital within 90 days of follow-up

Days alive without mechanical ventilation within 90 days of follow-up

Days alive without vasopressor/inotropic therapy within 90 days follow-up

Days alive without RRT within 90 days follow-up

Renal recovery at day 90

  1. ICU intensive care unit, RRT renal replacement therapy, SAR serious adverse reaction