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

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.

Study Overview

• Status: Unknown
• Conditions: Hypotension and Shock
• Intervention / Treatment: Drug: Isotonic crystalloid solution resuscitation; Drug: Colloid solution resuscitation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Recruiting
      • Siriraj Hospital
      • Contact: Surat Tongyoo, MD.; Phone Number: +6624198534; Email: surat_Ty@yahoo.co.uk
      • Contact: Chairat Permpikul, MD.; Phone Number: +6624108534
      • Sub-Investigator: Praphan Laophannarai, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Crystalloid; Isotonic crystalloid solution resuscitation	Drug: Isotonic crystalloid solution resuscitation; Patient will receive normal saline or Ringer lactate or other balance salt solution during fluid resuscitation for shock reversal.; Other Names: Crystalloid
ACTIVE_COMPARATOR: Crystalloid plus Colloid; Colloid solution resuscitation	Drug: Isotonic crystalloid solution resuscitation; Patient will receive normal saline or Ringer lactate or other balance salt solution during fluid resuscitation for shock reversal.; Other Names: Crystalloid; Drug: Colloid solution resuscitation; Patient will receive 5% albumin or gelatin solution during shock resuscitation; Other Names: Colloid plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	Dead from any causes within 28 days after enrollment	28 days
Hospital mortality	Dead from any causes during hospital admission	90 days
Total fluid resuscitation within 24 hours	Total volume of fluid resuscitation the patient received within 24 hours after enrollment	24 hours
Renal replacement therapy	Patient who required acute renal replacement therapy during admission	28 days

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: Siriraj Hospital
• Investigators: Study Director: Chairat Permpikul, MD., Siriraj Hospital

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: JAMA. 2013 Mar 12;311(10):1071. Regnier, Jean [corrected to Reignier, Jean]; Cle'h, Christophe [corrected to Clec'h, Christophe].

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ANTICIPATED): August 1, 2018
• Study Completion (ANTICIPATED): November 1, 2018

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (ESTIMATE): May 25, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): May 25, 2016
• Last Update Submitted That Met QC Criteria: May 24, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: crystalloid; colloid; Shock resuscitation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Shock; Hypotension; Pharmaceutical Solutions
• Other Study ID Numbers: Si685/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO