Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04043598 |
Other study ID # |
CRYSTALLBrain |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 24, 2022 |
Est. completion date |
July 2026 |
Study information
Verified date |
December 2023 |
Source |
Insel Gruppe AG, University Hospital Bern |
Contact |
Anna S Messmer, MD |
Phone |
+41316322111 |
Email |
anna.messmer[@]insel.ch |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Patients with subarachnoid hemorrhage are prone to suffer from dysnatriemia. Evidence shows
that hyponatriemia is associated with increased incidence of vasospasm, brain swelling and
mortality in these patients. Patients with subarachnoid hemorrhage often require large
amounts of iv fluids in order to maintain euvolemia and support cardiocirculatory function.
Prior evidence shows that the type of infusion fluid significantly influences blood sodium
content. Hence, this study evaluated whether the sodium content of the infusion solution
impacts mortality and morbidity in patients with subarachnoid hemorrhage.
Description:
Background: Despite ongoing advances in critical care mortality and morbidity of patients
with subarachnoid hemorrhage remains high. Secondary brain injuries related to cerebral
vasospasm and consecutive ischemic brain injury and intracerebral edema are the main
contributors to mortality and morbidity in these patients. Evidence points towards low serum
sodium levels being one of the significant risk factors for of secondary brain injury in this
population. Previous studies show that fluid resuscitation with normal saline results in
higher serum sodium levels and higher serum osmolality when compared to balanced infusates in
patients with subarachnoid hemorrhage.
Aim: The primary objective of this study is to evaluate whether the use of a sodium-rich
infusion (normal saline) results in better clinical outcome when compared to a
sodium-depleted infusion (lactated Ringer's) in patients with subarachnoid hemorrhage. The
primary endpoint will be the occurrence of clinically relevant vasospasm requiring immediate
treatment. In addition, the investigators will assess other relevant complications such as
long and short-term mortality, significant brain edema requiring conservative therapy or/and
operative hemicraniectomy, as well as further patient-relevant outcomes such as days on organ
support, postoperative infections, length of stay and long-term disability/mortality.
Study intervention: All patients admitted to a participating hospital with the diagnosis of
intracerebral bleeding will be screened and if eligible, randomized to one of the study arms.
Individual patient's consent will be sought. Thereafter, patients will receive only the
allocated study fluid for fluid maintenance and resuscitation from study inclusion until
ICU/intermediate care (IMC) discharge. Neurological evaluation will be performed hourly for
the initial phase and thereafter two hourly. Serum sodium, osmolality, fluid, water and
electrolyte balance as well as acid-base homeostasis will be evaluated daily. Further,
specific assessment of renal, cardiac and immune function takes place at 5 pre-specified
time-points (day 1,3,7,10 and at ICU/IMC discharge).
After ICU/IMC discharge patients will be followed for evaluation of secondary endpoints.
Long-term disability will be assessed by telephone interview based on the modified the
Rankin-Scale and the Glasgow Outcome Scale Extended.
Sample Size: Sample size calculation was based upon the investigators' ICU's registry data.
In 2017, 44.38% patients with subarachnoid hemorrhage reached the predefined endpoint of
clinically relevant vasospasm requiring immediate intervention. A clinically relevant effect
size was determined to be an improvement in outcome of 15%. Based on these results a patient
number of n = 160 for each group was determined under estimation of a 15% drop out rate.