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A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial.

ABSTRACT: Optimal resuscitation of hypotensive trauma patients has not been defined. This trial was performed to assess the feasibility and safety of controlled resuscitation (CR) versus standard resuscitation (SR) in hypotensive trauma patients.Patients were enrolled and randomized in the out-of-hospital setting. Nineteen emergency medical services (EMS) systems in the Resuscitation Outcome Consortium participated. Eligible patients had an out-of-hospital systolic blood pressure (SBP) of 90 mm Hg or lower. CR patients received 250 mL of fluid if they had no radial pulse or an SBP lower than 70 mm Hg and additional 250-mL boluses to maintain a radial pulse or an SBP of 70 mm Hg or greater. The SR group patients received 2 L initially and additional fluid as needed to maintain an SBP of 110 mm Hg or greater. The crystalloid protocol was maintained until hemorrhage control or 2 hours after hospital arrival.A total of 192 patients were randomized (97 CR and 95 SR). The CR and SR groups were similar at baseline. The mean (SD) crystalloid volume administered during the study period was 1.0 L (1.5) in the CR group and 2.0 L (1.4) in the SR group, a difference of 1.0 L (95% confidence interval [CI], 0.6-1.4). Intensive care unit-free days, ventilator-free days, renal injury, and renal failure did not differ between the groups. At 24 hours after admission, there were 5 deaths (5%) in the CR group and 14 (15%) in the SR group (adjusted odds ratio, 0.39; 95% CI, 0.12-1.26). Among patients with blunt trauma, 24-hour mortality was 3% (CR) and 18% (SR) with an adjusted odds ratio of 0.17 (0.03-0.92). There was no difference among patients with penetrating trauma (9% vs. 9%; adjusted odds ratio, 1.93; 95% CI, 0.19-19.17).CR is achievable in out-of-hospital and hospital settings and may offer an early survival advantage in blunt trauma. A large-scale, Phase III trial to examine its effects on survival and other clinical outcomes is warranted.Therapeutic study, level I.

SUBMITTER: Schreiber MA

PROVIDER: S-EPMC4375962 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial.

Schreiber Martin A MA Meier Eric N EN Tisherman Samuel A SA Kerby Jeffrey D JD Newgard Craig D CD Brasel Karen K Egan Debra D Witham William W Williams Carolyn C Daya Mohamud M Beeson Jeff J McCully Belinda H BH Wheeler Stephen S Kannas Delores D May Susanne S McKnight Barbara B Hoyt David B DB

The journal of trauma and acute care surgery 20150401 4

<h4>Background</h4>Optimal resuscitation of hypotensive trauma patients has not been defined. This trial was performed to assess the feasibility and safety of controlled resuscitation (CR) versus standard resuscitation (SR) in hypotensive trauma patients.<h4>Methods</h4>Patients were enrolled and randomized in the out-of-hospital setting. Nineteen emergency medical services (EMS) systems in the Resuscitation Outcome Consortium participated. Eligible patients had an out-of-hospital systolic blood ...[more]

PMID: 25807399

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Project description:Background:Septic shock is a public health problem with high mortality. There remains a knowledge gap regarding the optimal resuscitation fluid to improve clinical outcomes, and the underlying mechanism by which fluids exert their effect. Shock-induced endotheliopathy (SHINE) is thought to be a shared pathophysiologic mechanism associated with worsened outcomes in critically ill trauma and sepsis patients. SHINE is characterized by breakdown of the glycocalyx-a network of membrane-bound proteoglycans and glycoproteins that covers the endothelium. This has been associated with capillary leakage and microvascular thrombosis, organ dysfunction, and mortality. Biomarkers of SHINE have been shown to correlate with clinical outcomes in patients with septic shock. Interventions to mitigate SHINE may improve outcomes in patients with septic shock. In surgical/trauma patients with septic shock, initial plasma resuscitation as compared with balanced crystalloid (BC) resuscitation will mitigate biomarkers of SHINE and improve clinical outcomes. Methods:A pilot, single-center randomized controlled trial (RCT) will compare initial plasma to BC resuscitation in surgical and trauma patients with septic shock. Patients will be enrolled based on a Sepsis Screening Score of ?4 with a suspected source of infection. Patient randomization only occurs if they meet the criteria: (1) hypotension with mean arterial pressure <65?mm Hg, and (2) evidence of hypoperfusion including lactic acid >4?mmol/L, altered mental status or decreased urine output of <0.5?mL/kg in the past hour. Results:The primary outcome is a reduction in serum biomarkers at 6?hours. Secondary outcomes will include clinical outcomes such as intensive care unit-free days, organ dysfunction, and in-hospital mortality. Discussion:This trial will provide insights into the effects of initial plasma resuscitation on SHINE. Furthermore, it will provide unbiased estimates regarding the feasibility, safety, and clinical efficacy of plasma resuscitation in septic shock on which to base subsequent adequately powered multicenter RCTs. Trail registration number:ClinicalTrials.gov (NCT03366220).

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Project description:The seventh edition of the American Academy of Pediatrics Neonatal Resuscitation Program recommends the use of a cardiac monitor in infants that need resuscitation. Previous trials have shown that EKG heart rate is available before pulse rate from a pulse oximeter. To date no trial has looked at how the availability of electrocardiogram (EKG) affects clinical interventions in the delivery room.To determine whether the availability of an EKG heart rate value and tracing to the clinical team has an effect on physiologic measures and related interventions during the stabilization of preterm infants.Forty (40) premature infants enrolled in a neuro-monitoring study (The Neu-Prem Trial: NCT02605733) who had an EKG monitor available were randomized to have the heart rate information from the bedside EKG monitor either displayed or not displayed to the clinical team. Heart rate, oxygen saturation, FiO2 and mean airway pressure from a data acquisition system were recorded every 2 seconds. Results were averaged over 30 seconds and the differences analyzed using two-tailed t-test. Interventions analyzed included time to first change in FiO2, first positive pressure ventilation, first increase in airway pressure, and first intubation.There were no significant differences in time to clinical interventions between the blinded and unblinded group, despite the unblinded group having access to a visible heart rate at 66 +/- 20 compared to 114 +/- 39 seconds for the blinded group (p < .0001). Pulse rate from oximeter was lower than EKG heart rate during the first 2 minutes of life, but this was not significant.EKG provides an earlier, and more accurate heart rate than pulse rate from an oximeter during stabilization of preterm infants, allowing earlier intervention. All interventions were started earlier in the unblinded EKG group but these numbers were not significant in this small trial. Earlier EKG placement before pulse oximeter placement may affect other interventions, but this needs further study.

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A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial.

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A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial.

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