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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial of Crystalloid Alone Versus Crystalloid Plus Colloid in Shock Resuscitation

Conditions
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Hypotension and Shock

Intervention / Treatment
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* Drug: Isotonic crystalloid solution resuscitation
* Drug: Colloid solution resuscitation


Participation Criteria
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Eligibility Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Crystalloid<br>Isotonic crystalloid solution resuscitation | Drug: Isotonic crystalloid solution resuscitation<br>* Patient will receive normal saline or Ringer lactate or other balance salt solution during fluid resuscitation for shock reversal.<br>* Other names: Crystalloid;|
| Active Comparator: Crystalloid plus Colloid<br>Colloid solution resuscitation | Drug: Isotonic crystalloid solution resuscitation<br>* Patient will receive normal saline or Ringer lactate or other balance salt solution during fluid resuscitation for shock reversal.<br>* Other names: Crystalloid;Drug: Colloid solution resuscitation<br>* Patient will receive 5% albumin or gelatin solution during shock resuscitation<br>* Other names: Colloid plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who had shock reversal | Shock reversal was defined by mean arterial blood pressure > 65 mmHg plus lactate clearance more than 10% | 6 hours after initial resuscitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | Dead from any causes within 28 days after enrollment | 28 days | 
| Hospital mortality | Dead from any causes during hospital admission | 90 days | 
| Total fluid resuscitation within 24 hours | Total volume of fluid resuscitation the patient received within 24 hours after enrollment | 24 hours | 
| Renal replacement therapy | Patient who required acute renal replacement therapy during admission | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shock resuscitation, colloid, crystalloid