Crystalloid Fluid Choice and Neurological Outcome in Patients After Subarachnoid Haemorrhage

NCT04043598 | Recruiting DMC

• 1 other identifier: CRYSTALLBrain
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Subarachnoid Hemorrhage; Critical Illness; Infusion Fluid; Sodium Disorder

Outcome Measures

Primary Outcomes (1)

• Number of patients with clinically relevant vasospasms

  Defined as new neurologic deficit requiring immediate intervention

  From ICU admission until discharge (usually within the first 21 days)

Secondary Outcomes (9)

• Number of ICU deaths

  From ICU admission until discharge (usually within the first 21 days)

• Number of In-hospital deaths

  From hospital admission to hospital discharge (usually within the first 21 days)

• Number of severe vasospasms requiring endovascular treatment

  From hospital admission to hospital discharge (usually within the first 21 days)

• Number of patients needing decompressive hemicraniectomy

  From hospital admission to hospital discharge (usually within the first 21 days)

• Difference in modified RankingScale

  At day 90 and 180

Study Arms (2)

high sodium infusion fluid

ACTIVE COMPARATOR

Patients will exclusively receive 0.9% saline (sodium content 154mmol/l) for fluid maintenance and resuscitation from study inclusion until ICU/intermediate care (IMC) discharge.

Drug: 0.9% Sodium-chloride

low sodium infusion fluid

ACTIVE COMPARATOR

Patients will exclusively receive lactated Ringer's (sodium content 130mmol/l) for fluid maintenance and resuscitation from study inclusion until ICU/intermediate care (IMC) discharge.

Drug: Ringer's Lactate

Interventions

0.9% Sodium-chloride DRUG

We will compare two already established treatment protocols: the use of normal saline versus lactated Ringer's for fluid therapy in patients with subarachnoid hemorrhage.

high sodium infusion fluid

Ringer's Lactate DRUG

We will compare two already established treatment protocols: the use of normal saline versus lactated Ringer's for fluid therapy in patients with subarachnoid hemorrhage.

low sodium infusion fluid

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients suffering from non-traumatic subarachnoid haemorrhage.

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (3)

Department of perioperative Intensive Care Medicine

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

RECRUITING

Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland

Bern, 3010, Switzerland

RECRUITING

Department of Intensive Care Medicine

Geneva, 1205, Switzerland

RECRUITING

Related Publications (1)

• Messmer AS, Pitteloud M, Quintard H, Pietsch U, Muller M, Filipovic M, Jakob SM, Z'Graggen WJ, Schefold JC, Pfortmueller CA. CRYSTALLBrain: crystalloid fluid choice and neurological outcome in patients with non-traumatic subarachnoid haemorrhage-a study protocol for a multi-centre randomised double-blind clinical trial. Trials. 2025 Oct 17;26(1):422. doi: 10.1186/s13063-025-09099-9.

  PMID: 41107997 BACKGROUND

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Critical Illness

Interventions

Sodium Chloride; Ringer's Lactate

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Anna S Messmer, MD

  Department of Intensive Care, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna S Messmer, MD

CONTACT

+41316322111; anna.messmer@insel.ch

Research Nurses Department of Intensive Care

CONTACT

+41316322111; kim.researchnurses@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind randomized
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-center investigator-initiated randomized-controlled double blind clinical trial comparing to already established treatment protocols.

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: May 24, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)