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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-11-30

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.

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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.

Conditions

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Hypotension and Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crystalloid

Isotonic crystalloid solution resuscitation

Group Type PLACEBO_COMPARATOR

Isotonic crystalloid solution resuscitation

Intervention Type DRUG

Patient will receive normal saline or Ringer lactate or other balance salt solution during fluid resuscitation for shock reversal.

Crystalloid plus Colloid

Colloid solution resuscitation

Group Type ACTIVE_COMPARATOR

Isotonic crystalloid solution resuscitation

Intervention Type DRUG

Patient will receive normal saline or Ringer lactate or other balance salt solution during fluid resuscitation for shock reversal.

Colloid solution resuscitation

Intervention Type DRUG

Patient will receive 5% albumin or gelatin solution during shock resuscitation

Interventions

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Isotonic crystalloid solution resuscitation

Patient will receive normal saline or Ringer lactate or other balance salt solution during fluid resuscitation for shock reversal.

Intervention Type DRUG

Colloid solution resuscitation

Patient will receive 5% albumin or gelatin solution during shock resuscitation

Intervention Type DRUG

Other Intervention Names

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Crystalloid Colloid plus

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No