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A Comparison of Crystalloid Alone Versus Crystalloid Plus Colloid in Shock Resuscitation

Not Applicable
Conditions
Hypotension and Shock
Interventions
Drug: Isotonic crystalloid solution resuscitation
Drug: Colloid solution resuscitation
Registration Number
NCT02782819
Lead Sponsor
Mahidol University
Brief Summary

Fluid resuscitation is the most effective treatment of shock. Isotonic crystalloid solution is the current recommended initial fluid resuscitation. However, this kind of fluid has high volume of distribution and may require large volume administration before achieve therapeutic goal of shock reversal. There are rising concern about the delay in shock reversal and adverse consequences of large amount volume of fluid therapy. Colloid fluid have been used as the alternate fluid resuscitation, aiming to limit the volume of fluid resuscitation and promote shock reversal. Whether colloid infusion can improve shock reversal rate and decrease complication associated with fluid resuscitation, had inconclusive information.

Detailed Description

Fluid resuscitation is the most effective treatment of shock. Isotonic crystalloid solution is the current recommended initial fluid resuscitation. However, this kind of fluid has high volume of distribution and may require large volume administration before achieve therapeutic goal of shock reversal. There are rising concern about the delay in shock reversal and adverse consequences of large amount volume of fluid therapy. Colloid fluid have been used as the alternate fluid resuscitation, aiming to limit the volume of fluid resuscitation and promote shock reversal. Data from a recent randomized controlled study showed the improve long term survival among shock patients whose resuscitated with colloid solution. There were evidence about the increase incidence of acute kidney injury among critically ill patients who received hydroxyethyl starch, a previously worldwide used colloid solution. For septic shock, the leading cause of shock in current situation, resuscitation with albumin may associated with better outcome, while increasing mortality had been reported among the patient who received hydroxyethyl starch. Whether colloid infusion can improve shock reversal rate and decrease complication associated with fluid resuscitation, had inconclusive information.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
320
Inclusion Criteria
  • Age at least 18 years old
  • New onset of shock within 24 hours
  • Mean arterial blood pressure less than 65 mmHg or systolic blood pressure less than 60% of patient's baseline blood pressure
  • Evidence of poor tissue perfusion including: urine output less than 0.5 mL/kg/hr, lactate more than 2 mmol/L, alteration of consciousness without other explanation
  • Evidence of fluid inadequacy (CVP < 12 mmHg, Pulmonary capillary wedge pressure < 18 mmHg) or evidence of fluid responsive (IVC diameter variation > 15%, pulse pressure variation > 15%, positive fluid challenge test)
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Exclusion Criteria
  • Prolong shock more than 24 hours
  • Received colloid solution more than 1,000 mL in previous 72 hours
  • Do not resuscitation documented patient
  • Contraindication for fluid therapy including: suspected cardiogenic shock, evidence of pulmonary edema, history of anaphylaxis after fluid therapy
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CrystalloidIsotonic crystalloid solution resuscitationIsotonic crystalloid solution resuscitation
Crystalloid plus ColloidIsotonic crystalloid solution resuscitationColloid solution resuscitation
Crystalloid plus ColloidColloid solution resuscitationColloid solution resuscitation
Primary Outcome Measures
NameTimeMethod
Proportion of patients who had shock reversal6 hours after initial resuscitation

Shock reversal was defined by mean arterial blood pressure \> 65 mmHg plus lactate clearance more than 10%

Secondary Outcome Measures
NameTimeMethod
Hospital mortality90 days

Dead from any causes during hospital admission

Total fluid resuscitation within 24 hours24 hours

Total volume of fluid resuscitation the patient received within 24 hours after enrollment

Mortality rate28 days

Dead from any causes within 28 days after enrollment

Renal replacement therapy28 days

Patient who required acute renal replacement therapy during admission

Trial Locations

Locations (1)

Siriraj Hospital

🇹🇭

Bangkoknoi, Bangkok, Thailand

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