Clinical trial NCT02782819: A Comparison of Crystalloid Alone Versus Crystalloid Plus Colloid in Shock Resuscitation
Official title: A Randomized Controlled Trial of Crystalloid Alone Versus Crystalloid Plus Colloid in Shock Resuscitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotension and Shock
Keywords: Shock resuscitation
colloid
crystalloid
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Siriraj Hospital
First posted: 2016-05-25
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who had shock reversal
timeFrame: 6 hours after initial resuscitation
Secondary outcomes:
measure: Mortality rate
timeFrame: 28 days
measure: Hospital mortality
timeFrame: 90 days
measure: Total fluid resuscitation within 24 hours
timeFrame: 24 hours
measure: Renal replacement therapy
timeFrame: 28 days
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Chairat Permpikul, MD.
role: STUDY_DIRECTOR
References:
citation: Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. No abstract available.
citation: Annane D, Siami S, Jaber S, Martin C, Elatrous S, Declere AD, Preiser JC, Outin H, Troche G, Charpentier C, Trouillet JL, Kimmoun A, Forceville X, Darmon M, Lesur O, Reignier J, Abroug F, Berger P, Clec'h C, Cousson J, Thibault L, Chevret S; CRISTAL Investigators. Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting with hypovolemic shock: the CRISTAL randomized trial. JAMA. 2013 Nov 6;310(17):1809-17. doi: 10.1001/jama.2013.280502.