Microsoft PowerPoint - HES or saline pptx

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1 HYDROXYETHYL STARCH OR SALINE FOR FLUID RESUSCITATION IN INTENSIVE CARE N Engl J Med Nov 15;367(20): 本檔僅供內部教學使用檔案內所使用之照片之版權仍屬於原期刊公開使用時, 須獲得原期刊之同意授權 R 黃心治

2 Background 0.9% sodium chloride (saline) is the most commonly used fluid hydroxyethyl starch (HES) is the most frequently used colloid

3 Is HES safe? Several studies have questioned the safety of HES in critically ill patients particular in the risk of acute kidney injury concentrated HES solutions (10%) with a molecular weight of more than 200 kd and a molar substitution ratio (the number of hydroxyethyl groups per glucose molecule) of more than 0.5

4 Now We use lower concentration (6%) with a molecular weight of 130 kd and molar substitution ratios of 0.38 to recent Scandinavian trial reporting that the use of 6% HES (130/0.42) significantly increased mortality in patients with severe sepsis and septic shock Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med2012;367:

5 So large-scale, randomized, controlled trial evaluate the safety and efficacy of 6% HES (130/0.4) in 0.9% saline as compared with 0.9% saline alone

6 METHODS Study Oversight Patients Study Randomization and Treatment Outcome Measures Data and Study Management Statistical Analysis

7 Study Oversight investigator-initiated, multicenter, prospective, blinded, parallel-group, randomized, controlled trial 32 hospitals in Australia and New Zealand approved by the human research ethics committee

8 Patients >18y/o admitted to ICU require fluid resuscitation (defined as the administration of a bolus of intravenous fluid over and above that required for maintenance or replacement fluids) Fluid was administered to correct hypovolemia at any time during the patient's ICU admission

9 Patients exclusion criteria: Patients who had received more than 1000 ml of HES before screening impending or current dialysis-dependent renal failure evidence of intracranial hemorrhage on cranial computed tomography

10 Study Randomization and Treatment 6% HES (130/0.4) in 0.9% saline (Voluven, Fresenius Kabi) or 0.9% saline in indistinguishable Freeflex 500-ml bags study fluid was administered to a maximum dose of 50 ml/kg/day, followed by open-label 0.9% saline for the remainder of the 24-hour period. Study fluid was stopped in patients who were treated with any mode of renal-replacement therapy. Resuscitation fluids outside the ICU was not controlled

11 Outcome Measures primary outcome: all-cause mortality(90 days) Secondary outcomes within the 90-day follow-up period incidence of acute kidney injury(refile) renal-replacement therapy new organ failures for cardiovascular, respiratory, coagulation, and liver systems duration of mechanical ventilation and renal-replacement therapy cause-specific mortality.

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13 Outcome Measures Primary outcome (also examined in six subgroup pairs on the basis of baseline characteristics acute kidney injury (RIFLE-R and RIFLE-I categories) sepsis at randomization trauma with or without traumatic brain injury the score (<25 vs. 25) on the APACHE II (ranging from 0 to 71, with higher scores indicating an increased risk of death) receipt or nonreceipt of HES before

14 Outcome Measures Tertiary outcomes duration of ICU stay and hospital admission the rate of death in the ICU and hospital

15 RESULTS-Patient December 2009 through January patients in 32 adult medicalsurgical ICUs in Australia and New Zealand 3500 patients HES group 3500 patients saline group two groups similar characteristics at baseline The primary outcome 3315 patients (94.7%) in the HES group 3336 patients (95.3%) in the saline group.

16 RESULTS-Patient

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20 RESULTS-Fluid Therapy and Treatment Effects In the HES group for the first 4 days significantly less study fluid than the saline group significantly less nonstudy fluid than the saline group significantly more blood products than the saline group significantly higher central venous pressure no significant between-group differences in heart rate, mean arterial pressure, and lactate levels during the first 4 days

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22 RESULTS

23 RESULTS no significant difference during the 90 days after randomization

24 RESULTS no significant heterogeneity in the effect of treatment on 90-day mortality in any of the predefined subgroups

25 RESULTS Serum Creatinine Levels and Urine Output through Day 6.

26 RESULTS Creatinine/urine-output components of each RIFLE category were analyzed separately relative risks of meeting the criteria for the risk of RIFLE-R or RIFLE-I were higher in the HES group than in the saline group

27 Discussion No significant difference in mortality at 90 days in a heterogeneous population of ICU patients The effect on mortality did not differ The effect on mortality did not differ significantly in six predefined subgroup pairs

28 Discussion-limitation the observed rate of death was lower than predicted Exclusion of patients with ICH and those whom clinicians considered unlikely to survive, as well as the inclusion of patients who had undergone elective surgery. Patients were recruited after admission to the ICU, when the requirements for fluid resuscitation are often less than those for patients in the emergency department or the operating room.

29 Discussion-conclusion not provide evidence that resuscitation with 6% HES (130/0.4) provides any clinical benefit use of HES: increased rate of renal replacement therapy. selection of resuscitation fluid in critically ill patients requires careful consideration of its safety, its potential effect on patient-centered outcomes, and its cost