CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
NCT05958342 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1050
Last updated 2026-04-14
Summary
The CAlcium and VAsopressin following Injury Early Resuscitation (CAVALIER) Trial is a proposed 4 year, double-blind, mutli-center, prehospital and early in hospital phase randomized trial designed to determine the efficacy and safety of prehospital calcium and early in hospital vasopressin in patients at risk of hemorrhagic shock.
Conditions
Interventions
- DRUG
-
Calcium Gluconate
1 gram calcium gluconate provided via intravenous or intraosseous access over approximately 2-5 minutes
- DRUG
-
Vasopressin
4 unit vasopressin bolus followed by vasopressin infusion at 0.04 U/min for eight hours
- DRUG
-
saline placebo
saline placebo volume matched to prehospital or in hospital phase
Sponsors & Collaborators
-
United States Department of Defense
collaborator FED -
Jason Sperry
lead OTHER
Principal Investigators
-
Jason Sperry, MD · University of Pittsburgh
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-30
- Primary Completion
- 2027-03-31
- Completion
- 2028-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage
NCT02176837 ·Status: TERMINATED ·Phase: PHASE2
-
Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage
NCT07246629 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Clevidipine for Vasospasm After Subarachnoid Hemorrhage (SAH)
NCT02011321 ·Status: WITHDRAWN ·Phase: PHASE2
-
Saline Versus Balanced Crystalloid in Traumatic Brain Injury
NCT06953674 ·Status: RECRUITING ·Phase: PHASE3
-
The Effect of Prehospital Combination of Epinephrine, Vasopressin, and Steroid in OHCA
NCT06203847 ·Status: RECRUITING ·Phase: NA
-
Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury
NCT00930202 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.
NCT07319208 ·Status: RECRUITING ·Phase: PHASE3
-
Osmotic Therapy for Treatment of Intracranial Hypertension for Traumatic Brain Injury
NCT01215019 ·Status: WITHDRAWN ·Phase: NA
-
Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm
NCT00873015 ·Status: COMPLETED ·Phase: PHASE2
-
Prevention of Vasospasm in SAH Through CSF Treatment
NCT04490161 ·Status: RECRUITING ·Phase: NA
-
Preventive Sodium Lactate and Traumatic Brain Injury
NCT00995683 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Efficacy of the Use of Vasopressin as a Primary Vasoconstrictor in Critically Ill Patients
NCT06265259 ·Status: RECRUITING ·Phase: PHASE4
-
The Anaesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury
NCT05095857 ·Status: RECRUITING ·Phase: PHASE4
-
Early Induced Hypernatremia for the Prevention and Management of Brain Edema
NCT02798601 ·Status: WITHDRAWN ·Phase: NA
-
Hypernatremia for the Prevention and Treatment of Cerebral Edema in Traumatic Brain Injury
NCT01605357 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Registry of Patients in Shock Treated With Vasopressin
NCT06422975 ·Status: RECRUITING
-
Clevidipine in Neurocritical Patients
NCT05168059 ·Status: COMPLETED
-
Cervical Sympathetic Block in Patients With Cerebral Vasospasm
NCT05230134 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
NCT06402968 ·Status: RECRUITING
-
Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms
NCT02056574 ·Status: WITHDRAWN ·Phase: PHASE2
-
Field Randomization of Nerinetide (NA-1) Therapy in Early Responders
NCT02315443 ·Status: COMPLETED ·Phase: PHASE3
-
Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)
NCT00316004 ·Status: TERMINATED ·Phase: PHASE3
-
Continuous Hyperosomolar Therapy for Traumatic Brain-injured Patients
NCT03143751 ·Status: COMPLETED ·Phase: PHASE3
-
Calcium Administration in Life-saving Management During Massive Hemorrhage
NCT06820645 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2/PHASE3
-
The Efficacy and Safety of Cleviprex in Ventriculostomy Patients Requiring IV Antihypertensive Therapy
NCT01042574 ·Status: WITHDRAWN ·Phase: PHASE4