NCT02782819

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypotension and Shock

Interventions

Type	Name	Description
DRUG	Isotonic crystalloid solution resuscitation	Patient will receive normal saline or Ringer lactate or other balance salt solution during fluid resuscitation for shock reversal.
DRUG	Colloid solution resuscitation	Patient will receive 5% albumin or gelatin solution during shock resuscitation

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-08-01
• Completion: 2018-11-01
• First posted: 2016-05-25
• Last updated: 2016-05-25

Locations

1 site across 1 country: Thailand