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Briana Santaniello, MBA PharmD Candidate 2015 MANNITOL AND HYPERTONIC SALINE IN SUBDURAL HEMATOMA February 11, 2015.

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Presentation on theme: "Briana Santaniello, MBA PharmD Candidate 2015 MANNITOL AND HYPERTONIC SALINE IN SUBDURAL HEMATOMA February 11, 2015."— Presentation transcript:

1 Briana Santaniello, MBA PharmD Candidate 2015 MANNITOL AND HYPERTONIC SALINE IN SUBDURAL HEMATOMA February 11, 2015

2 After reviewing the patient case, the audience should be able to:  Recognize the treatment options for a subdural hematoma  Describe the mechanisms of action of these agents  Analyze available literature comparing the effectiveness of these treatments  Determine if current guidelines should be updated to reflect recent literature suggestive of dose change OBJECTIVES

3  CC: Unresponsive s/p witnessed fall with subsequent emesis  HPI:  83 yo F  Sustained witnessed fall  Found vomiting by son-in-law  Felt unwell & requested to lay down  Progressively more somnolent  Son-in-law called 9-11.  PMH/PSH: sick sinus syndrome s/p pacemaker, HTN, HLD, osteoporosis, hypothyroidism MEET THE PATIENT: MD

4  FH: unavailable  SH: lives with husband who has dementia; babysitter of 3 year old grandchild; has 3 children  Allergies: midazolam  Reaction – not specified  Home medications (doses unknown):  warfarin  amlodipine  levothyroxine  simvastatin MEET THE PATIENT: MD (CONTINUED)

5  Physical examination/presentation to ED:  Somnolent  Contusion/laceration to R side of face & bridge of nose  Pupils equal and sluggishly reactive (3 mm bilaterally)  Vomitus and blood obstructing airway MEET THE PATIENT: MD (CONTINUED) Presents to ED: GCS 9 Decompensation ensued & left pupil became fixed & dilated: GCS 7 Intubation

6 VITAL SIGNS AND PERTINENT INFORMATION Upon ArrivalDecompensation BP (mmHg)150/84200/88 O 2 sat97%88% Pulse (bpm)10580 RR (breaths/min)2220 POC (mg/dL)161------ INR------2.3

7  Height: 162 cm  Weight: 66.8 kg  Serum creatinine: 0.9 mg/dL  Round to 1 based on age > 65 years old  Creatinine clearance: 40.9 mL/min ADDITIONAL INFORMATION

8 MEDICATIONS GIVEN IN ED Decision to intubate fentanyl 100 mcg IV etomidate & rocuronium propofol Signs of impending herniation Contusion to head Pupil blown Decerebrate posturing Suspected subdural hematoma mannitol 100 g IV Sent for CT scan

9  Massive holohemispheric subdural hematoma: Left RESULTS OF CT SCAN

10 TREATMENT OF SUBDURAL HEMATOMA Craniotomy Burr hole trepanation/trephination Decompressive craniectomy Head elevation at 30° angle Osmotic diuretics/Hyperosmolar therapy Surgical hematoma evacuation Non- pharmacologic Pharmacologic -Brain Trauma Foundation’s 2007 Guidelines for the Management of Severe Traumatic Brain Injury -Wilkins RH, Rengachary SS. Neurosurgery. 2nd ed. New York:. McGraw Hill;1996:2603-2720

11  Reversal of anticoagulant is necessary  Immediate cessation of anticoagulants & antiplatelets +  vitamin K 10 mg by slow IV infusion or  recombinant human factor VIIa (rFVIIa) or  fresh frozen plasma (FFP) or  prothrombin complex concentrate (PCC) URGENT SURGICAL PROCEDURES IN ANTICOAGULATED PATIENTS

12  MANNITOL  Mechanism of action:  HYPERTONIC SALINE  Mechanism of action PHARMACOLOGICAL OPTIONS osmotic gradient between CSF and subarachnoid space ↓ subarachnoid space pressure ↓ICP osmotic gradient: intracellular fluid moves extracellularly ↑ intravascular blood volume ↑ plasma sodium ↓ brain water Fink ME. Osmotherapy for Intracranial Hypertension: Mannitol Versus Hypertonic Saline. Continuum Lifelong Learning Neurol 20012;18(3):640-654.

13  Available formulations:  20% solution  25% in vials  Dose:  0.5 to 1 g/kg  Doses < 0.5 g/kg: less efficacious, shorter DOA  Administration  IV bolus over 20 minutes  Requires filter  crystallization MANNITOL IN SUBDURAL HEMATOMA Fink ME. Osmotherapy for Intracranial Hypertension: Mannitol Versus Hypertonic Saline. Continuum Lifelong Learning Neurol 20012;18(3):640-654.

14  Adverse Effects  Electrolyte abnormalities (hypernatremia, hypokalemia, metabolic acidosis)  Hypotension  Monitoring  ICP  Serum osmolarity  DNE 320 mOsm/L  Osmotic gradient: ideally ≥ 10 mOsm MANNITOL IN SUBDURAL HEMATOMA (CONTINUED) Fink ME. Osmotherapy for Intracranial Hypertension: Mannitol Versus Hypertonic Saline. Continuum Lifelong Learning Neurol 2012;18(3):640-654. Mannitol. Package Insert. Baxter Health Care. 2011. Old Toongabbie, NSW.

15  Complications  CHF with pulmonary edema  Acute renal failure  Rebound hypertension with cessation of therapy  Contraindications  Hypersensitivity  Anuria from severe renal disease  Severe pulmonary edema, HF  Hyperosmolarity prior to initial dose  Severe dehydration  Metabolic edema  Progressive renal disease MANNITOL IN SUBDURAL HEMATOMA (CONTINUED) Fink ME. Osmotherapy for Intracranial Hypertension: Mannitol Versus Hypertonic Saline. Continuum Lifelong Learning Neurol 2012;18(3):640-654. Mannitol. Package Insert. Baxter Health Care. 2011. Old Toongabbie, NSW.

16  Available formulations: 2%, 3%, 5%, 7%, 23.4%  Less potent diuretic than mannitol  ↔ intravascular volume  ↑ blood pressure, CO, cerebral blood flow  Dose: 5-6 mL/kg bolus dose of 3% administered over 30 minutes  Can vary depending on hospital’s protocol  Administration  IV bolus  Preferably administered via central line  high concentration  Can be administered peripherally in trauma room  Maximum of 100 mL/hr for up to 5 hours per site HYPERTONIC SALINE IN SUBDURAL HEMATOMA Fink ME. Osmotherapy for Intracranial Hypertension: Mannitol Versus Hypertonic Saline. Continuum Lifelong Learning Neurol 20012;18(3):640-654.

17  Side Effects  Hypokalemia  supplemental potassium  Dehydration  Monitoring  serum Na+ (ideally < 160 mEq/L or < 180 mEq/L in refractory cases)  serum osmolarity (target < 320 mOsmol/L)  fluid status (intake/output)  body weight  CXR (pulmonary edema) HYPERTONIC SALINE IN SUBDURAL HEMATOMA (CONTINUED) Fink ME. Osmotherapy for Intracranial Hypertension: Mannitol Versus Hypertonic Saline. Continuum Lifelong Learning Neurol 20012;18(3):640-654.

18  Complications  hyperchloremic acidosis  With repeated doses or continuous infusion  Central pontine myelinolysis (CPM)  Renal failure  Cardiac arrhythmias  Hemolysis  CHF with pulmonary edema  Contraindications  Chronic hyponatremia (i.e. SIADH) due to risk of CPM HYPERTONIC SALINE IN SUBDURAL HEMATOMA (CONTINUED) Fink ME. Osmotherapy for Intracranial Hypertension: Mannitol Versus Hypertonic Saline. Continuum Lifelong Learning Neurol 20012;18(3):640-654.

19  Double Blind Study of Hypertonic Saline vs Mannitol in the Management of Increased Intracranial Pressure (ICP)  Study withdrawn prior to enrollment  Unfeasible timeline to consent prior to intervention  No Class I evidence supporting use of one agent over the other  Mortazavi et al: literature review with meta-analysis comparing hypertonic saline to mannitol MANNITOL VS. HYPERTONIC SALINE

20  Mortazavi et al: PubMed literature search of all clinical studies in which HTS was used for elevated ICP  12 compared hypertonic saline with mannitol  7 RCTs, 1 prospective non-randomized study, 4 retrospective studies  Results:  3: hypertonic saline not clinically superior to mannitol for ICP reduction/outcome  9: suggested hypertonic saline is clinically superior to mannitol for ICP reduction MANNITOL VS. HYPERTONIC SALINE Mortazavi MM, Romeo AK, Deep A, et al. Hypertonic saline for treating raised intracranial pressure: literature review with meta- analysis. J Neurosurg 2012;116:210-221

21  Among the 9 trials supporting use of hypertonic saline over mannitol:  Total of 236 subjects among the 9 trials  Different concentrations of hypertonic saline used in each trial  Some trials used continuous infusion; others used bolus dose  Conflicting results on mortality in hypertonic saline groups MANNITOL VS. HYPERTONIC SALINE

22  Neurocritical Care Society practice patterns survey  mannitol: 45.1%  More comfortable with agent, no central venous access required, more effective  hypertonic saline: 54.9%  Fewer side effects, better long-term benefits, less of a rebound effect, easier titration, less associated with renal failure HYPERTONIC SALINE IN SUBDURAL HEMATOMA (CONTINUED) Mortazavi MM, Romeo AK, Deep A, et al. Hypertonic saline for treating raised intracranial pressure: literature review with meta- analysis. J Neurosurg 2012;116:210-221

23  Randomized trial in 178 comatose adult patients diagnosed with acute traumatic subdural hematoma over 4 year period  Randomly assigned to 1 of 2 groups:  High-dose mannitol group: 91 patients  Conventional-dose mannitol group: 87 patients  All were administered 0.6-0.7g/kg mannitol as fast IV infusion, followed by normal saline solution administered via rapid IV infusion at 6-7 mL/kg  25 to 30 minutes later, high-dose mannitol group received additional 0.6-0.7g/kg dose of mannitol when pupillary widening was still observed HIGH-DOSE MANNITOL Cruz J, Minoja G, Okuchi G. Improving Clinical Outcomes from Acute Subdural Hematomas with the Emergency Preoperative Administration of High Doses of Mannitol: A Randomized Trial. Neurosurgery 2001;49(4):864-871.

24  All underwent standard craniotomies with clot removal, received fentanyl and propofol, and had head elevation 30° post-craniotomy  Monitored via ECG, pulse oximetry, expired PCO 2, ICP, MAP  Results:  6 months after acute traumatic brain injury, mortality rates were as follows:  High-dose mannitol: 14.3% (13 patients)  Conventional-dose mannitol: 25.3% (22 patients)  P < 0.01  Overall clinical outcomes significantly better in patients who received high-dose mannitol (p < 0.01) HIGH-DOSE MANNITOL Cruz J, Minoja G, Okuchi G. Improving Clinical Outcomes from Acute Subdural Hematomas with the Emergency Preoperative Administration of High Doses of Mannitol: A Randomized Trial. Neurosurgery 2001;49(4):864-871.

25  MD weighs 66.8 kg  1 g/kg x 66.8 kg = 66.8 g  MD given 100 g ??? MANNITOL FOR MD

26  Traditionally dosed 1g/kg  CrCl: 40.9 mL/minute  Poor prognosis  Potential for renal harm balanced with potential for better ICP reduction THOUGHTS ON APPROPRIATE DOSE

27 TAKE HOME POINTS

28 REFERENCES 1. Brain Trauma Foundation’s 2007 Guidelines for the Management of Severe Traumatic Brain Injury 2. Wilkins RH, Rengachary SS. Neurosurgery. 2nd ed. New York:. McGraw Hill;1996:2603-2720 3. Fink ME. Osmotherapy for Intracranial Hypertension: Mannitol Versus Hypertonic Saline. Continuum Lifelong Learning Neurol 20012;18(3):640-654. 4.Mannitol. Package Insert. Baxter Health Care. 2011. Old Toongabbie, NSW. 5. Mortazavi MM, Romeo AK, Deep A, et al. Hypertonic saline for treating raised intracranial pressure: literature review with meta-analysis. J Neurosurg 2012;116:210-221 6. Cruz J, Minoja G, Okuchi G. Improving Clinical Outcomes from Acute Subdural Hematomas with the Emergency Preoperative Administration of High Doses of Mannitol: A Randomized Trial. Neurosurgery 2001;49(4):864-871.

29 Thank You! QUESTIONS?


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