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

NCT02782819 | Unknown DMC

• 1 other identifier: Si685/2014
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension and Shock

Keywords

Shock resuscitation; colloid; crystalloid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mortality rate

  28 days

• Hospital mortality

  90 days

• Total fluid resuscitation within 24 hours

  24 hours

• Renal replacement therapy

  28 days

Study Arms (2)

Crystalloid

PLACEBO COMPARATOR

Isotonic crystalloid solution resuscitation

Drug: Isotonic crystalloid solution resuscitation

Crystalloid plus Colloid

ACTIVE COMPARATOR

Colloid solution resuscitation

Drug: Isotonic crystalloid solution resuscitation; Drug: Colloid solution resuscitation

Interventions

Isotonic crystalloid solution resuscitation DRUG

Patient will receive normal saline or Ringer lactate or other balance salt solution during fluid resuscitation for shock reversal.

Also known as: Crystalloid

Crystalloid; Crystalloid plus Colloid

Colloid solution resuscitation DRUG

Patient will receive 5% albumin or gelatin solution during shock resuscitation

Also known as: Colloid plus

Crystalloid plus Colloid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• Siriraj Hospital: collaborator

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (2)

• 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.

  PMID: 24171518 BACKGROUND

• 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.

  PMID: 24108515 BACKGROUND

MeSH Terms

Conditions

Hypotension; Shock

Interventions

Crystalloid Solutions; Colloids

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations; Complex Mixtures; Dosage Forms

Study Officials

• Chairat Permpikul, MD.

  Siriraj Hospital

  STUDY DIRECTOR

Central Study Contacts

Surat Tongyoo, MD.

CONTACT

+6624198534; surat_Ty@yahoo.co.uk

Prapan Laophannarai, MD.

CONTACT

+66914018833; praphan113@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 25, 2016
• Study Start: September 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: November 1, 2018
• Last Updated: May 25, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)