Actively Recruiting
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-04-29
320
Participants Needed
3
Research Sites
21 weeks
Total Duration
Researchers are studying patients with subarachnoid hemorrhage, a condition where bleeding occurs in the space around the brain. These patients often suffer from low sodium levels in the blood, which is linked to serious complications like brain swelling, vasospasm, and higher risk of death. The study aims to find out if the type of intravenous fluid given, based on its sodium content, affects patients' recovery and survival. The trial compares two types of intravenous fluids for fluid maintenance and resuscitation in these patients: 0.9% sodium chloride (normal saline), which has a higher sodium content, and lactated Ringer's solution, which has a lower sodium content. Patients receive only their assigned fluid from the time they enter the study until they are discharged from the intensive or intermediate care unit. Neurological evaluations are done hourly at first, then every two hours, while blood tests and assessments of kidney, heart, and immune function occur at specific times during the stay. Participants are closely monitored for complications including vasospasm, brain swelling, infections, and mortality during their ICU stay, usually up to 21 days. After discharge, patients are followed up with telephone interviews to assess long-term outcomes like disability and cognitive function at 90 and 180 days. The study also tracks length of stay, organ support days, and other health measures to understand how the fluid choice impacts recovery and survival.
CONDITIONS
Crystalloid Fluid Choice and Neurological Outcome in Patients After Subarachnoid Haemorrhage
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Duration - Up to 24 hours since diagnosis
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - From study inclusion until ICU/intermediate care discharge (usually within the first 21 days)
Participants receive either a high sodium infusion (0.9% saline) or a low sodium infusion (lactated Ringer's) for fluid maintenance and resuscitation from study inclusion until discharge from ICU or intermediate care.
Hourly neurological evaluations initially, then every two hours; daily blood tests; specific assessments on days 1, 3, 7, 10, and at ICU/IMC discharge
Duration - Up to 180 days after discharge
Participants are followed after ICU/intermediate care discharge to assess long-term neurological outcomes and mortality through telephone interviews.
Telephone interviews at day 90 and day 180
Total: 3 locations
1
Department of perioperative Intensive Care Medicine
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
Actively Recruiting
2
Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland
Bern, Switzerland, 3010
Actively Recruiting
3
Department of Intensive Care Medicine
Geneva, Switzerland, 1205
Actively Recruiting
A
Anna S Messmer, MD
R
Research Nurses Department of Intensive Care
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Anna S Messmer, Matthieu Pitteloud, Hervé Quintard...
https://pubmed.ncbi.nlm.nih.gov/41107997Akshitkumar M Mistry
https://pubmed.ncbi.nlm.nih.gov/39379751