Randomized pilot trial of intensive management of blood pressure or volume expansion in subarachnoid hemorrhage (improves)

Kei Togashi, Aaron M. Joffe, Laligam Sekhar, Louis Kim, Arthur Lam, Norbert Yanez, Jo Ann Broeckel-Elrod, Anne Moore, Steve Deem, Nita Khandelwal, Michael J. Souter, Miriam Treggiari

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

BACKGROUND: Volume expansion and hypertension are widely used for the hemodynamic management of patients with subarachnoid hemorrhage. OBJECTIVE: To investigate the feasibility, adherence, and retention in a trial of volume expansion and blood pressure manipulation to prevent delayed cerebral ischemia. METHODS: A randomized pilot trial using a 2-way factorial design allocating patients within 72 hours of subarachnoid hemorrhage to either normovolemia (NV) or volume expansion (HV) and simultaneously to conventional (CBP) or augmented blood pressure (ABP) for 10 days. The study endpoints were protocol adherence and retention to follow-up. The quality of endpoints for a larger trial were 6-month modified Rankin Scale score, comprehensive neurobehavioral assessment, delayed cerebral ischemia, new stroke, and discharge disposition. RESULTS: Twenty patients were randomized and completed follow-up. The overall difference in daily mean intravenous fluid intake was 2099 mL (95% confidence interval [CI]: 867, 3333), HV vs NV group. The overall mean systolic blood pressure difference was 5 mm Hg (95% CI: 24.65, 14.75), ABP vs CBP group. Adverse events included death (n = 1), delayed cerebral ischemia (n = 1), and pulmonary complications (n = 3). There were no differences in modified Rankin Scale score between HV and NV (difference 0.1; 95% CI:21.26, 1.46, P = .87) or between ABP and CBP groups (20.5, 95% CI:21.78, 0.78, P = .43). Neuropsychological scores were similar between HV vs NV, but tended to be worse in ABP (576 27) vs CBP group (85 6 21, P = .04). CONCLUSION: This pilot study showed adequate feasibility and excellent retention to followup. Given the suggestion of possible worse neurobehavioral outcome with ABP, a larger trial to determine the optimal blood pressure management in this patient population is warranted. (ClinTrials.gov NCT01414894.).

Original languageEnglish (US)
Pages (from-to)125-134
Number of pages10
JournalNeurosurgery
Volume76
Issue number2
DOIs
StatePublished - 2015

Fingerprint

Subarachnoid Hemorrhage
Blood Volume
Blood Pressure
Brain Ischemia
Confidence Intervals
Hemodynamics
Stroke
Hypertension
Lung

Keywords

  • Behavior mechanisms
  • Cerebral vasospasm
  • Critical care
  • Delayed ischemic neurological deficits
  • Hypertension
  • Hypervolemia
  • Triple H therapy

ASJC Scopus subject areas

  • Clinical Neurology
  • Surgery
  • Medicine(all)

Cite this

Randomized pilot trial of intensive management of blood pressure or volume expansion in subarachnoid hemorrhage (improves). / Togashi, Kei; Joffe, Aaron M.; Sekhar, Laligam; Kim, Louis; Lam, Arthur; Yanez, Norbert; Broeckel-Elrod, Jo Ann; Moore, Anne; Deem, Steve; Khandelwal, Nita; Souter, Michael J.; Treggiari, Miriam.

In: Neurosurgery, Vol. 76, No. 2, 2015, p. 125-134.

Research output: Contribution to journalArticle

Togashi, K, Joffe, AM, Sekhar, L, Kim, L, Lam, A, Yanez, N, Broeckel-Elrod, JA, Moore, A, Deem, S, Khandelwal, N, Souter, MJ & Treggiari, M 2015, 'Randomized pilot trial of intensive management of blood pressure or volume expansion in subarachnoid hemorrhage (improves)', Neurosurgery, vol. 76, no. 2, pp. 125-134. https://doi.org/10.1227/NEU.0000000000000592
Togashi, Kei ; Joffe, Aaron M. ; Sekhar, Laligam ; Kim, Louis ; Lam, Arthur ; Yanez, Norbert ; Broeckel-Elrod, Jo Ann ; Moore, Anne ; Deem, Steve ; Khandelwal, Nita ; Souter, Michael J. ; Treggiari, Miriam. / Randomized pilot trial of intensive management of blood pressure or volume expansion in subarachnoid hemorrhage (improves). In: Neurosurgery. 2015 ; Vol. 76, No. 2. pp. 125-134.
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AU - Kim, Louis

AU - Lam, Arthur

AU - Yanez, Norbert

AU - Broeckel-Elrod, Jo Ann

AU - Moore, Anne

AU - Deem, Steve

AU - Khandelwal, Nita

AU - Souter, Michael J.

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N2 - BACKGROUND: Volume expansion and hypertension are widely used for the hemodynamic management of patients with subarachnoid hemorrhage. OBJECTIVE: To investigate the feasibility, adherence, and retention in a trial of volume expansion and blood pressure manipulation to prevent delayed cerebral ischemia. METHODS: A randomized pilot trial using a 2-way factorial design allocating patients within 72 hours of subarachnoid hemorrhage to either normovolemia (NV) or volume expansion (HV) and simultaneously to conventional (CBP) or augmented blood pressure (ABP) for 10 days. The study endpoints were protocol adherence and retention to follow-up. The quality of endpoints for a larger trial were 6-month modified Rankin Scale score, comprehensive neurobehavioral assessment, delayed cerebral ischemia, new stroke, and discharge disposition. RESULTS: Twenty patients were randomized and completed follow-up. The overall difference in daily mean intravenous fluid intake was 2099 mL (95% confidence interval [CI]: 867, 3333), HV vs NV group. The overall mean systolic blood pressure difference was 5 mm Hg (95% CI: 24.65, 14.75), ABP vs CBP group. Adverse events included death (n = 1), delayed cerebral ischemia (n = 1), and pulmonary complications (n = 3). There were no differences in modified Rankin Scale score between HV and NV (difference 0.1; 95% CI:21.26, 1.46, P = .87) or between ABP and CBP groups (20.5, 95% CI:21.78, 0.78, P = .43). Neuropsychological scores were similar between HV vs NV, but tended to be worse in ABP (576 27) vs CBP group (85 6 21, P = .04). CONCLUSION: This pilot study showed adequate feasibility and excellent retention to followup. Given the suggestion of possible worse neurobehavioral outcome with ABP, a larger trial to determine the optimal blood pressure management in this patient population is warranted. (ClinTrials.gov NCT01414894.).

AB - BACKGROUND: Volume expansion and hypertension are widely used for the hemodynamic management of patients with subarachnoid hemorrhage. OBJECTIVE: To investigate the feasibility, adherence, and retention in a trial of volume expansion and blood pressure manipulation to prevent delayed cerebral ischemia. METHODS: A randomized pilot trial using a 2-way factorial design allocating patients within 72 hours of subarachnoid hemorrhage to either normovolemia (NV) or volume expansion (HV) and simultaneously to conventional (CBP) or augmented blood pressure (ABP) for 10 days. The study endpoints were protocol adherence and retention to follow-up. The quality of endpoints for a larger trial were 6-month modified Rankin Scale score, comprehensive neurobehavioral assessment, delayed cerebral ischemia, new stroke, and discharge disposition. RESULTS: Twenty patients were randomized and completed follow-up. The overall difference in daily mean intravenous fluid intake was 2099 mL (95% confidence interval [CI]: 867, 3333), HV vs NV group. The overall mean systolic blood pressure difference was 5 mm Hg (95% CI: 24.65, 14.75), ABP vs CBP group. Adverse events included death (n = 1), delayed cerebral ischemia (n = 1), and pulmonary complications (n = 3). There were no differences in modified Rankin Scale score between HV and NV (difference 0.1; 95% CI:21.26, 1.46, P = .87) or between ABP and CBP groups (20.5, 95% CI:21.78, 0.78, P = .43). Neuropsychological scores were similar between HV vs NV, but tended to be worse in ABP (576 27) vs CBP group (85 6 21, P = .04). CONCLUSION: This pilot study showed adequate feasibility and excellent retention to followup. Given the suggestion of possible worse neurobehavioral outcome with ABP, a larger trial to determine the optimal blood pressure management in this patient population is warranted. (ClinTrials.gov NCT01414894.).

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