| Methods |
Patients were stratified according to amount of extravasated blood on CT (assessed by means of Fisher's grading system). The first included patient per Fisher category was randomly (method unknown) entered into one of the two treatment strategies. Thereafter, consecutive patients were entered alternately into the groups.
Outcome assessment was not blinded. |
| Participants |
Location: 1 centre in Norway.
Rx: 16 patients;
control: 16 patients.
Inclusion criteria: (1) operative clipping < 72 hours after SAH; (2) H&H grade I to III; (3) written informed consent. Exclusion criteria: (1) age > 75 years; (2) congestive heart failure; (3) pregnancy; (4) renal insufficiency. Patients were well balanced for major determinants of DCI and clinical outcome. |
| Interventions |
Study treatment was started after operative clipping of aneurysm.
Intervention: triple‐H fluid management therapy for 12 days, aiming for CVP 8 to 12 mmHg, hematrocrit between 0.30 and 0.35 and postoperative MAP > 20 mmHg higher than pre‐operative MAP. Baseline fluid management consisted of 2000 ml of 5% dextrose and 2000 ml of 0.9% saline and 1000 to 1500 ml colloids.
Control: normovolemic fluid therapy aiming for neutral fluid balance. Baseline fluid management consisted of 1000 ml of 5% dextrose and 1000 ml of 0.9% saline. No albumin or colloids were administered. |
| Outcomes |
(1) MAP and CVP daily; (2) Scandinavian Neurological Stroke Scale assessments; (3) TCD daily; (4) CT on day 8; (5) SPECT on days 4, 8 and 12; (6) GOS at 14 days and at one year; (7) clinical vasospasm (not defined); (8) complications. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
High risk |
C ‐ Inadequate |
