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

Martin Schreiber, Eric N. Meier, Samuel A. Tisherman, Jeffrey D. Kerby, Craig Newgard, Karen Brasel, Debra Egan, William Witham, Carolyn Williams, Mohamud Ramzan Daya, Jeff Beeson, Belinda McCully, Stephen Wheeler, Delores Kannas, Susanne May, Barbara Mcknight, David B. Hoyt

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Abstract

BACKGROUND: Optimal resuscitation of hypotensive trauma patients has not been defined. This trialwas performed to assess the feasibility and safety of controlled resuscitation (CR) versus standard resuscitation (SR) in hypotensive trauma patients. METHODS: 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. RESULTS: 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], 0.6Y1.4). Intensive care unitYfree 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, 0.12Y1.26). Among patients with blunt trauma, 24-hour mortality was 3% (CR) and 18% (SR) with an adjusted odds ratio of 0.17 (0.03Y0.92). There was no difference among patients with penetrating trauma (9% vs. 9%; adjusted odds ratio, 1.93; 95% CI, 0.19Y19.17). CONCLUSION: CR is achievable in out-of-hospital and hospital settings and may offer an early survival advantage in blunt trauma. A largescale, Phase III trial to examine its effects on survival and other clinical outcomes is warranted.

Original languageEnglish (US)
Pages (from-to)687-697
Number of pages11
JournalJournal of Trauma and Acute Care Surgery
Volume78
Issue number4
DOIs
StatePublished - Apr 4 2015

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Resuscitation
Wounds and Injuries
Blood Pressure
Odds Ratio
Confidence Intervals
Survival
Emergency Medical Services
Mechanical Ventilators
Critical Care
Renal Insufficiency

Keywords

  • Controlled resuscitation
  • hemorrhage control
  • hypotension

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine
  • Surgery

Cite this

A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients : Results of a prospective randomized pilot trial. / Schreiber, Martin; Meier, Eric N.; Tisherman, Samuel A.; Kerby, Jeffrey D.; Newgard, Craig; Brasel, Karen; Egan, Debra; Witham, William; Williams, Carolyn; Daya, Mohamud Ramzan; Beeson, Jeff; McCully, Belinda; Wheeler, Stephen; Kannas, Delores; May, Susanne; Mcknight, Barbara; Hoyt, David B.

In: Journal of Trauma and Acute Care Surgery, Vol. 78, No. 4, 04.04.2015, p. 687-697.

Research output: Contribution to journalArticle

Schreiber, Martin ; Meier, Eric N. ; Tisherman, Samuel A. ; Kerby, Jeffrey D. ; Newgard, Craig ; Brasel, Karen ; Egan, Debra ; Witham, William ; Williams, Carolyn ; Daya, Mohamud Ramzan ; Beeson, Jeff ; McCully, Belinda ; Wheeler, Stephen ; Kannas, Delores ; May, Susanne ; Mcknight, Barbara ; Hoyt, David B. / A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients : Results of a prospective randomized pilot trial. In: Journal of Trauma and Acute Care Surgery. 2015 ; Vol. 78, No. 4. pp. 687-697.
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abstract = "BACKGROUND: Optimal resuscitation of hypotensive trauma patients has not been defined. This trialwas performed to assess the feasibility and safety of controlled resuscitation (CR) versus standard resuscitation (SR) in hypotensive trauma patients. METHODS: 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. RESULTS: 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], 0.6Y1.4). Intensive care unitYfree 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, 0.12Y1.26). Among patients with blunt trauma, 24-hour mortality was 3{\%} (CR) and 18{\%} (SR) with an adjusted odds ratio of 0.17 (0.03Y0.92). There was no difference among patients with penetrating trauma (9{\%} vs. 9{\%}; adjusted odds ratio, 1.93; 95{\%} CI, 0.19Y19.17). CONCLUSION: CR is achievable in out-of-hospital and hospital settings and may offer an early survival advantage in blunt trauma. A largescale, Phase III trial to examine its effects on survival and other clinical outcomes is warranted.",
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T1 - A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients

T2 - Results of a prospective randomized pilot trial

AU - Schreiber, Martin

AU - Meier, Eric N.

AU - Tisherman, Samuel A.

AU - Kerby, Jeffrey D.

AU - Newgard, Craig

AU - Brasel, Karen

AU - Egan, Debra

AU - Witham, William

AU - Williams, Carolyn

AU - Daya, Mohamud Ramzan

AU - Beeson, Jeff

AU - McCully, Belinda

AU - Wheeler, Stephen

AU - Kannas, Delores

AU - May, Susanne

AU - Mcknight, Barbara

AU - Hoyt, David B.

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N2 - BACKGROUND: Optimal resuscitation of hypotensive trauma patients has not been defined. This trialwas performed to assess the feasibility and safety of controlled resuscitation (CR) versus standard resuscitation (SR) in hypotensive trauma patients. METHODS: 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. RESULTS: 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], 0.6Y1.4). Intensive care unitYfree 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, 0.12Y1.26). Among patients with blunt trauma, 24-hour mortality was 3% (CR) and 18% (SR) with an adjusted odds ratio of 0.17 (0.03Y0.92). There was no difference among patients with penetrating trauma (9% vs. 9%; adjusted odds ratio, 1.93; 95% CI, 0.19Y19.17). CONCLUSION: CR is achievable in out-of-hospital and hospital settings and may offer an early survival advantage in blunt trauma. A largescale, Phase III trial to examine its effects on survival and other clinical outcomes is warranted.

AB - BACKGROUND: Optimal resuscitation of hypotensive trauma patients has not been defined. This trialwas performed to assess the feasibility and safety of controlled resuscitation (CR) versus standard resuscitation (SR) in hypotensive trauma patients. METHODS: 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. RESULTS: 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], 0.6Y1.4). Intensive care unitYfree 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, 0.12Y1.26). Among patients with blunt trauma, 24-hour mortality was 3% (CR) and 18% (SR) with an adjusted odds ratio of 0.17 (0.03Y0.92). There was no difference among patients with penetrating trauma (9% vs. 9%; adjusted odds ratio, 1.93; 95% CI, 0.19Y19.17). CONCLUSION: CR is achievable in out-of-hospital and hospital settings and may offer an early survival advantage in blunt trauma. A largescale, Phase III trial to examine its effects on survival and other clinical outcomes is warranted.

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KW - hemorrhage control

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