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

Primary Purpose

Hypotension and Shock

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Isotonic crystalloid solution resuscitation
Colloid solution resuscitation
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension and Shock focused on measuring Shock resuscitation, colloid, crystalloid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Crystalloid

Crystalloid plus Colloid

Arm Description

Isotonic crystalloid solution resuscitation

Colloid solution resuscitation

Outcomes

Primary Outcome Measures

Proportion of patients who had shock reversal
Shock reversal was defined by mean arterial blood pressure > 65 mmHg plus lactate clearance more than 10%

Secondary Outcome Measures

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

Full Information

First Posted
May 16, 2016
Last Updated
May 24, 2016
Sponsor
Mahidol University
Collaborators
Siriraj Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02782819
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
Collaborators
Siriraj Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension and Shock
Keywords
Shock resuscitation, colloid, crystalloid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crystalloid
Arm Type
Placebo Comparator
Arm Description
Isotonic crystalloid solution resuscitation
Arm Title
Crystalloid plus Colloid
Arm Type
Active Comparator
Arm Description
Colloid solution resuscitation
Intervention Type
Drug
Intervention Name(s)
Isotonic crystalloid solution resuscitation
Other Intervention Name(s)
Crystalloid
Intervention Description
Patient will receive normal saline or Ringer lactate or other balance salt solution during fluid resuscitation for shock reversal.
Intervention Type
Drug
Intervention Name(s)
Colloid solution resuscitation
Other Intervention Name(s)
Colloid plus
Intervention Description
Patient will receive 5% albumin or gelatin solution during shock resuscitation
Primary Outcome Measure Information:
Title
Proportion of patients who had shock reversal
Description
Shock reversal was defined by mean arterial blood pressure > 65 mmHg plus lactate clearance more than 10%
Time Frame
6 hours after initial resuscitation
Secondary Outcome Measure Information:
Title
Mortality rate
Description
Dead from any causes within 28 days after enrollment
Time Frame
28 days
Title
Hospital mortality
Description
Dead from any causes during hospital admission
Time Frame
90 days
Title
Total fluid resuscitation within 24 hours
Description
Total volume of fluid resuscitation the patient received within 24 hours after enrollment
Time Frame
24 hours
Title
Renal replacement therapy
Description
Patient who required acute renal replacement therapy during admission
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Surat Tongyoo, MD.
Phone
+6624198534
Email
surat_Ty@yahoo.co.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Prapan Laophannarai, MD.
Phone
+66914018833
Email
praphan113@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chairat Permpikul, MD.
Organizational Affiliation
Siriraj Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surat Tongyoo, MD.
Phone
+6624198534
Email
surat_Ty@yahoo.co.uk
First Name & Middle Initial & Last Name & Degree
Chairat Permpikul, MD.
Phone
+6624108534
First Name & Middle Initial & Last Name & Degree
Praphan Laophannarai, MD.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24171518
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.
Results Reference
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PubMed Identifier
24108515
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. Erratum In: JAMA. 2013 Mar 12;311(10):1071. Regnier, Jean [corrected to Reignier, Jean]; Cle'h, Christophe [corrected to Clec'h, Christophe].
Results Reference
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A Comparison of Crystalloid Alone Versus Crystalloid Plus Colloid in Shock Resuscitation

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