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

Hypotension and Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02782819
• Other study ID #: Si685/2014
• Status: Recruiting
• Phase: N/A
• First received: May 16, 2016
• Last updated: May 24, 2016
• Start date: September 2014
• Est. completion date: November 2018

Study information

• Verified date: May 2016
• Source: Mahidol University
• Contact: Surat Tongyoo, MD.
• Phone: +6624198534
• Email: surat_Ty[@]yahoo.co.uk
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotension
• Hypotension and Shock
• Shock

Intervention

Drug:
• Isotonic crystalloid solution resuscitation
Patient will receive normal saline or Ringer lactate or other balance salt solution during fluid resuscitation for shock reversal.
• Colloid solution resuscitation
Patient will receive 5% albumin or gelatin solution during shock resuscitation

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

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

Outcome

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