Hypotension and Shock Clinical Trial
Official title:
A Randomized Controlled Trial of Crystalloid Alone Versus Crystalloid Plus Colloid in Shock Resuscitation
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.
Status | Recruiting |
Enrollment | 320 |
Est. completion date | November 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Siriraj Hospital | Bangkoknoi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University | Siriraj Hospital |
Thailand,
Annane D, Siami S, Jaber S, Martin C, Elatrous S, Declère AD, Preiser JC, Outin H, Troché 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. Erratum in: JAMA. 2013 Mar 12;311(10):1071. Régnier, Jean [corrected to Reignier, Jean]; Cle'h, Christophe [corrected to Clec'h, Christophe]. — View Citation
Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Mortality rate | Dead from any causes within 28 days after enrollment | 28 days | No |
Secondary | Hospital mortality | Dead from any causes during hospital admission | 90 days | No |
Secondary | Total fluid resuscitation within 24 hours | Total volume of fluid resuscitation the patient received within 24 hours after enrollment | 24 hours | No |
Secondary | Renal replacement therapy | Patient who required acute renal replacement therapy during admission | 28 days | Yes |
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