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Hypertonic Saline (7.2%) in 6% Hydroxyethyl Starch Reduces Intracranial Pressure and Improves Hemodynamics in a Placebo-Controll

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Hypertonic Saline (7.2%) in 6% Hydroxyethyl Starch Reduces Intracranial Pressure and Improves Hemodynamics in a Placebo-Controll Continuing Medical Education Article Hypertonic saline (7.2%) in 6% hydroxyethyl starch reduces intracranial pressure and improves hemodynamics in a placebo-controlled study involving stable patients with subarachnoid hemorrhage* Gunnar Bentsen, MD; Harald Breivik, MD, DMSc, FRCA; Tryggve Lundar, MD, DMSc; Audun Stubhaug, MD, DMSc LEARNING OBJECTIVES On completion of this article, the reader should be able to: 1. Describe the effects of hypertonic saline (7.2% saline in 6% hydroxyethyl starch 200/0.5) on intracranial pressure. 2. Compare the effects of hypertonic with normal saline on cerebral perfusion pressure. 3. Use this information in a clinical setting. All authors have disclosed that they have no financial relationships with or interests in any commercial companies pertaining to this educational activity. Lippincott CME Institute, Inc., has identified and resolved all faculty conflicts of interest regarding this educational activity. Visit the Critical Care Medicine Web site (www.ccmjournal.org) for information on obtaining continuing medical education credit. Objective: To compare the effects of a bolus infusion of hyper- was ؊5.6 (range, ؊0.8 to ؊12.2) mm Hg after 64 (range, 40 to tonic saline hydroxyethyl starch with the effects of normal saline 115) mins. Mean difference in cerebral perfusion pressure change placebo) on intracranial pressure (ICP) and cerebral perfusion pres- between the groups (HSS ؊ normal saline) was 5.4 mm Hg (95%) and mean difference in ,(002. ؍ sure in patients with spontaneous subarachnoid hemorrhage. confidence interval, 2.2 to 8.6; p Design and Setting: Prospective, randomized, single-blinded, cardiac index change, measured as the area under the curve for placebo-controlled study in a university hospital. the whole study period, corresponded to 0.2 L·min؊1·m؊2 (95% .(025. ؍ Patients: A total of 22 mechanically ventilated patients with confidence interval, 0.03 to 0.4; p spontaneous subarachnoid hemorrhage with stable ICP between Conclusions: In this placebo-controlled study involving spon- 10 and 20 mm Hg. taneous subarachnoid hemorrhage patients with normal to mod- Interventions: During the course of 30 mins, 2 mL/kg of either erately increased ICP, 2 mL/kg HSS reduced ICP and increased 7.2% saline in 6% hydroxyethyl starch 200/0.5 (HSS) or of normal cerebral perfusion pressure significantly. Maximum effect was saline was infused. The effects were observed for another 180 mins. reached at twice the infusion time of 30 mins. There were also Measurements and Main Results: Mean change in ICP after intervention (⌬ICP) calculated from the average of all observa- beneficial hemodynamic effects with increased cardiac index in the HSS group. (Crit Care Med 2006; 34:2912–2917) (tions was ؊3.3 (SD 2.6) mm Hg in the HSS group vs. ؊0.3 (SD 1.3 mm Hg in the normal saline group. Mean difference between the KEY WORDS: brain edema; hypertonic solutions; intracranial hy- -groups (HSS ؊ normal saline) was ؊3.0 mm Hg (95% confidence pertension; intracranial pressure; saline solution; hypertonic; sub Mean peak change after HSS arachnoid hemorrhage .(004. ؍ interval, ؊4.9 to ؊1.1; p ypertonic saline solutions 5, 6), and rebound increase in intracra- One of the limitations of these studies are an alternative to manni- nial pressure (ICP) (2, 7–11). Hypertonic has been the lack of placebo control, tol in the treatment of intra- saline has attenuated intracranial hyper- which makes it impossible to prove how cranial hypertension (1, 2). tension in a number of clinical trials (12– much of the measured effect can be at- HRepeated administrations of mannitol are 17). In studies comparing hypertonic sa- tributed to the hypertonic saline inter- associated with adverse effects such as line with mannitol, the results generally vention. The administration of osmoth- acute renal failure (3–5), hypovolemia (3, favor hypertonic saline (18–22). erapy is often one of several interventions applied almost simultaneously to unsta- ble patients. The fact that ICP is danger- *See also p. 3037. Copyright © 2006 by the Society of Critical Care ously high at the time of intervention Consultant (GB), Professor (HB), Associate Profes- Medicine and Lippincott Williams & Wilkins makes the use of a placebo unethical. We sor (AS), Department of Anesthesiology and Intensive DOI: 10.1097/01.CCM.0000245665.46789.7C Care, Professor (TL), Department of Neurosurgery, Rik- have previously, in a prospective observa- shospitalet-Radiumhospitalet Medical Center, Faculty tional study of spontaneous subarachnoid of Medicine, University of Oslo, Oslo, Norway. hemorrhage (SAH) patients with ICP of 2912 Crit Care Med 2006 Vol. 34, No. 12 Ͼ20 mm Hg, demonstrated an ICP re- 200/0.5 solution (HyperHAES, Fresenius Kabi four and six. The examiners were unaware of duction from a mean of 25 mm Hg to a AG). The observation period lasted from 10 the randomization method and unaware of the mean of 11 mm Hg after infusion of a mins before until 210 mins after the start of block size. Group allocations for all patients hypertonic saline solution (23). We could the infusion. Need for rescue treatment was were stored in sealed envelopes marked with also report an increase in cerebral perfu- defined by treatment failure limits for ICP and consecutive patient numbers only. To avoid CPP, which were an ICP of Ͼ20 mm Hg and a examiner bias, the envelopes remained un- sion pressure (CPP). This was done in a CPP of Ͻ60 mm Hg. Unless these limits were opened until inclusion was decided on and controlled intensive care setting. All reached during the observation period, the baseline data logging was established. No pa- other factors that influence ICP and CPP ventilation variables were kept unaltered, the tients were withdrawn after inclusion. The were kept stable during the trial. The aim infusion rates for vasopressors, analgesics, randomization code was not revealed until the of the present study was to validate these sedatives, and fluids were kept stable, the re- study was completed and all data had been findings with an even more laboratory- sistance in the external ventricular drainage entered and validated. like trial in which the patients were stable (EVD) was unchanged, and the patients were Statistics. The mean value of each patient’s before inclusion and hypertonic saline neither stimulated nor moved. measured variables from the 5 mins of regis- was compared with a solution that was Data Acquisition. ICP (intraparenchymal tration before the infusion served as the base- not expected to influence ICP and CPP. device, Codman, Raynham, MA), CPP, heart line. For data acquired electronically every 30 rate, arterial and central venous pressures secs, the mean values of all 5-min periods The present study also addresses the (zeroed at the level of the right atrium of the throughout the 210-min observation period question as to when one can expect to heart), and peripheral oxygen saturation were calculated and used for analysis. As rec- reach the maximum effect of a hypertonic (Siemens AG, Munich, Germany) were regis- ommended for statistical analysis of serial saline infusion. tered electronically every 30 secs (LabView, measurements by Matthews et al. (26), we National Instruments, Austin, TX). The pri- calculated the area under the curve for the PATIENTS AND METHODS mary author manually removed false arterial different variables in each patient and stan- blood pressure values due to blood sampling. dardized by the length of the study, 210 mins, This was a single-center study, performed This typically affected three consecutive re- to get the mean change for the whole period. in the intensive care unit of a university hos- cordings (90 secs). The use of an intraparen- For variables for which time intervals between pital that treats about 170 acute SAH patients chymal device for ICP monitoring is routine successive observations were constant, the annually. The Regional Ethics Committee for practice in our hospital in patients with severe simple mean of the observations was used. To Medical Research and the Norwegian Medi- SAH. This allows continuous ICP and CPP assess differences between the groups, un- cines Agency approved the protocol for the monitoring during EVD, even in situations in paired Student’s t-tests were used, with Welch study. All patients would be unconscious dur- which the EVD catheter is blocked by blood correction when there was unequal variance ing inclusion. A thorough evaluation of the clots. No additional sensors were used for the or Mann-Whitney tests when normality tests failed (GraphPad InStat version 3.05, Graph- risks and possible benefits to the patients was purpose of this study. Pad Software, San Diego, CA). therefore especially important, as underlined Arterial blood gases, pH, hemoglobin, and sodium (ABL 725, Radiometer, Denmark) in the Helsinki Declaration. Our search of the were measured before and 30, 90, and 210 relevant literature indicated minimal risk of RESULTS mins after start of the infusion. Cardiac index, adverse effects. Promising clinical results jus- intrathoracic blood volume index, and ex- tified further clinical trials with this critically From April 2002 through October 2004, travascular lung water index were registered 22 patients with acute, spontaneous SAH ill patient population. Informed consent was before and 30, 90, and 210 mins after start of impossible to obtain. According to Norwegian infusion by use of the PiCCO system (PiCCO, were included, 11 in each group. A total of legislation, one cannot obtain a legally valid Pulsion Medical Systems, Munich, Germany) 21 patients had hemorrhaged because of consent to medical research by proxy. Thus, in (24, 25). The catheters were introduced via the a ruptured aneurysm, and one patient agreement with our ethics committee, close femoral artery and the internal jugular or sub- was diagnosed with a fusiform dilation of relatives were given oral and written informa- clavian vein. the left vertebral artery.
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