Impact of fluid type on outcomes in patients with subarachnoid hemorrhage
Crystalloid Fluid Choice and Neurological Outcome in Patients After Subarachnoid Haemorrhage - a Multi-center Randomized Double-blind Clinical Trial
This study tests whether using different types of IV fluids can improve recovery for patients who have had a subarachnoid hemorrhage.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 3 sites (Sankt Gallen, Canton of St. Gallen and 2 other locations) |
| Trial ID | NCT04043598 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of different types of intravenous fluids on patients who have suffered a subarachnoid hemorrhage. It specifically compares sodium-rich normal saline to sodium-depleted lactated Ringer's solution to determine which fluid leads to better clinical outcomes. The primary focus is on the occurrence of vasospasm, a serious complication, as well as other factors such as mortality, brain edema, and overall patient recovery. The study aims to provide insights into how fluid choice can influence recovery in critically ill patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients diagnosed with non-traumatic subarachnoid hemorrhage.
Not a fit: Patients with major intra-cranial trauma or those who have limitations on therapy at admission may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols that enhance recovery and reduce complications for patients with subarachnoid hemorrhage.
How similar studies have performed: Previous studies have indicated that the type of infusion fluid can significantly affect sodium levels and patient outcomes, suggesting that this approach has merit.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All adult patients suffering from non-traumatic subarachnoid haemorrhage. Exclusion Criteria: * Patients with major intra-cranial trauma * Diagnosis of an AV-malformation as the source of subarachnoid hemorrhage on the primary CT/MRI or angiography * More than 24 hours after diagnosis of subarachnoid haemorrhage as diagnosed by cerebral imaging (CT scan or MRI) * Patients with clear limitation to therapy at hospital admission (eg ICU admission for evaluation of organ donation) * Declining of informed consent
Where this trial is running
Sankt Gallen, Canton of St. Gallen and 2 other locations
- Department of perioperative Intensive Care Medicine — Sankt Gallen, Canton of St. Gallen, Switzerland (Recruiting)
- Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland — Bern, Switzerland (Recruiting)
- Department of Intensive Care Medicine — Geneva, Switzerland (Recruiting)
Study contacts
- Principal investigator: Anna S Messmer, MD — Department of Intensive Care, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland
- Study coordinator: Anna S Messmer, MD
- Email: anna.messmer@insel.ch
- Phone: +41316322111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.