Table #2.
Intravenous fluid (ml/kg) and resuscitative measures delivered during the 72-hour study period, study outcomes, and adverse events; intention-to-treat analysis
| Restrictive fluid group (n=55) |
Usual care group (n=54) |
P value | |
|---|---|---|---|
| Intervention | |||
| Resuscitative IV fluid: ml/kga | |||
| Prior to randomization | 34.4 ± 13.2 | 36.2 ±14.3 | 0.49 |
| Randomization to 24 hoursb | 7.8 ± 13.3 | 16.6 ±23.2 | 0.02 |
| Hours 24 to 48 | 3.6 ± 11.4 | 6.8 ±11.2 | 0.15 |
| Hours 48 to 72 | 1.3 ± 4.4 | 1.5 ± 5.1 | 0.82 |
| Total | 47.1 ± 22.3 | 61.1 ± 32.0 | 0.01 |
| Non-resuscitative IV fluid and fluid totals | |||
| Non-resuscitative IV fluid, ml/kgc | 23.7 ± 17.5 | 37.6 ± 35.4 | 0.01 |
| Total all forms IV fluid, ml/kg | 70.8 ± 31.8 | 98.8 ± 54.5 | 0.002 |
| Resuscitative IV fluid as a fraction of total blood volumed | 0.79 ± 0.34 | 1.00 ± 0.49 | 0.01 |
| Adjunct Interventions: n (%) | |||
| Albumine | 14 (25.5) | 11 (20.4) | 0.65 |
| Blood transfusion | 10 (18.2) | 8 (14.8) | 0.80 |
| Stress dose steroidsf | 20 (36.0) | 20 (37.0) | >0.99 |
| Outcomes | |||
| Death: no./total (%) | |||
| 30-day mortality: primary outcome | 12/55 (21.8) | 12/54 (22.2) | >0.99 |
| 60-day mortality | 15/55 (27.3) | 15/54 (27.8) | >0.99 |
| New organ failure: n (%) | |||
| Cardiovascular – vasopressors for shock | 47/55 (85.4) | 43/54 (79.6) | 0.46 |
| Respiratory – new mechanical ventilationg | 15/53(28.3) | 17/52 (32.7) | 0.68 |
| Renal – new hemodialysish | 1/48 (2.1) | 2/53 (3.8) | >0.99 |
| Duration of organ support: median (IQR) | |||
| Vasopressor free daysi | 28 (26 to 29) | 28 (7 to 28) | 0.12 |
| Vasopressor hoursi | 17.0 (8.8 to 30.3) | 19.8 (9.8 to 57.8) | 0.33 |
| Ventilator free daysj | 26 (0 to 28) | 19 (1 to 28) | 0.91 |
| Mechanical ventilation hoursj | 16.8 (7.0 to 26.5) | 37.8 (22.0 to 126.5) | 0.02 |
| Use of hospital resources: median (IQR) | |||
| ICU length of stay hours | 53.5 (28.8 to 92.0) | 69.0 (26.3 to 105.8) | 0.61 |
| Hospital length of stay hours | 189.0 (95.3 to 294.5) | 179.3 (97.0 to 280.8) | 0.82 |
| Electrolyte measurements: mean, SDk | |||
| Change in chloride, mmol/L | 4.1 ± 4.3 | 5.5 ± 4.9 | 0.15 |
| Change in bicarbonate, mmol/L | 0.55 ± 3.9 | 1.2 ± 5.0 | 0.45 |
| Serious adverse events: | |||
| Myocardial infarction n (%) | 3 (5.5) | 0 (0) | 0.24 |
| Acute kidney injuryl | 1 (1.8) | 1 (1.9) | >0.99 |
| Required re-intubation | 1 (1.8) | 3 (5.6) | 0.36 |
| Disseminated intravascular coagulation | 0 (0) | 0 (0) | |
| Limb ischemia | 0 (0) | 0 (0) |
± indicates standard deviation
Six participants (5 restrictive and 1 standard) were randomized after 24 hours, none received additional IV fluid during that time
Non-resuscitative fluid includes all IV fluid administered with medications in volumes of ≥100ml
(Total resuscitative IV fluid)/(total blood volume); total blood volume = (70/√(BMI/22))
Only 25% albumin available at study sites
Hydrocortisone 100mg three times daily or 50mg four times daily
Four participants with mechanical ventilation at baseline excluded
Eight participants with dialysis at baseline excluded
Includes the 90 participants who were on vasopressors, out of 30 days
Includes the 32 participants with new mechanical ventilation, out of 30 days
Includes only the participants alive at 72 hours, ± indicates standard deviation
Defined as a doubling of creatinine from the first recorded value during the study period