Crystalloid Versus Hydroxyethyl Starch Trials (CHEST)

This study has been completed.
Sponsor:
Collaborators:
University of Sydney
Australian and New Zealand Intensive Care Society Clinical Trials Group
Fresenius Kabi
Information provided by (Responsible Party):
The George Institute
ClinicalTrials.gov Identifier:
NCT00935168
First received: July 1, 2009
Last updated: November 14, 2012
Last verified: February 2012

July 1, 2009
November 14, 2012
December 2009
April 2012   (final data collection date for primary outcome measure)
All cause mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00935168 on ClinicalTrials.gov Archive Site
  • Renal failure requiring renal replacement therapy will be assessed using hospital records. [ Time Frame: During intensive care Unit (ICU) stay after randomisation up to 90 days ] [ Designated as safety issue: Yes ]
  • Other organ failures will be assessed using the Sequential Organ Failure Assessment (SOFA) score which is based on biochemical and bio-physiological parameters recorded in the hospital record. [ Time Frame: During ICU stay after randomisation up to 90 days ] [ Designated as safety issue: Yes ]
  • ICU, hospital and 28 day mortality [ Time Frame: At 28 days and 6 months after randomisation ] [ Designated as safety issue: Yes ]
  • Quality of life will be assessed using the EQ-5D questionnaire. [ Time Frame: 6 months after randomisation ] [ Designated as safety issue: No ]
  • Functional status will be assessed using the Glasgow Outcome score. [ Time Frame: 6 months after randomisation. ] [ Designated as safety issue: No ]
  • Renal failure requiring renal replacement therapy will be assessed using hospital records. [ Time Frame: During intensive care Unit (ICU) stay after randomisation ] [ Designated as safety issue: Yes ]
  • Other organ failures will be assessed using the Sequential Organ Failure Assessment (SOFA) score which is based on biochemical and bio-physiological parameters recorded in the hospital record. [ Time Frame: During ICU stay after randomisation ] [ Designated as safety issue: Yes ]
  • ICU, hospital and 28 day mortality [ Time Frame: At 28 days and 6 months after randomisation ] [ Designated as safety issue: Yes ]
  • Quality of life will be assessed using the EQ-5D questionnaire. [ Time Frame: 6 months after randomisation ] [ Designated as safety issue: No ]
  • Functional status will be assessed using the Glasgow Outcome score. [ Time Frame: 6 months after randomisation. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Crystalloid Versus Hydroxyethyl Starch Trials
A Multi-centre Randomized Controlled Trial of Fluid Resuscitation With Starch (6%Hydroxyethyl Starch 130/0.4) Compared to Saline (0.9% Sodium Chloride) in Intensive Care Patients on Mortality

The aim of this study is to determine whether patients in the Intensive Care Unit who receive fluid resuscitation with either hydroxyethyl starch (a synthetic colloid solution) or saline (a salt solution), have an increased rate of survival at 90 days.

Patients in intensive care units frequently require intravenous fluid because the treating clinicians consider that the patient's blood pressure or circulating blood volume needs to be increased to clinically acceptable levels. Despite fluid resuscitation being a fundamental part of standard medical treatment for critically ill patients, clinicians are left with uncertainty about the optimal choice and volume of fluid that should be administered.

This study is a prospective, multi−centre, blinded, randomised controlled trial.

The two fluids being compared are 0.9% sodium chloride (saline) and 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride,(starch). The null hypothesis assumes no difference in all-cause mortality between patients given starch in comparison with patients given saline for fluid resuscitation.

Each patient who meets all inclusion criteria and none of the exclusion criteria will be randomised to receive one of the two study fluids for fluid resuscitation.

Once treatment has been assigned the participant will continue to receive either starch or saline only for all fluid resuscitation requirements in intensive care. The treating clinical team will decide the amount and frequency of the fluid given for resuscitation based on standard care.

During their ICU stay, participants will have information on the use of study fluids, other fluids, kidney function, blood pressure, heart rate and other haemodynamic data that is routinely recorded in the medical record collected. All participants will be followed up at day 90 and at 6 months after randomisation.

The participants status (alive, in hospital and length of stay) will be recorded at day 28 and day 90 after randomisation. At the 6 month follow−up all participants or their carer will be interviewed by telephone using standardised questionnaires about the participant's quality of life. In addition, participants who were admitted to intensive care with a traumatic brain injury will be interviewed to determine how well the participant is recovering.

After all patients have completed the 6 months of follow−up, data linkage will also be used to link patients (in NSW only) to health databases in order to obtain information on their use of health services.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Intensive Care
  • Drug: 6% Hydroxy-ethyl starch (130/0.4)
    Maximum dose of 50ml/kg/day of 6% hydroxy-ethyl starch (130/0.4) for intravascular volume fluid resuscitation
    Other Name: Voluven 6%
  • Drug: Saline
    Maximum dose of 50ml/kg/day of saline for intravascular volume fluid resuscitation
    Other Name: Sodium Chloride 0.9%
  • Experimental: Hydroxy-ethyl starch
    Intravenous fluid resuscitation with 6% Hydroxy-ethyl starch (130/0.4)
    Intervention: Drug: 6% Hydroxy-ethyl starch (130/0.4)
  • Active Comparator: Saline
    Intravenous fluid resuscitation with saline (0.9% sodium chloride)
    Intervention: Drug: Saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7000
September 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent has been obtained or if not possible, the procedure for obtaining informed consent has been approved by the ethics committee.
  • Fluid resuscitation is required to increase or maintain intravascular volume that is in addition to maintenance fluids, enteral and parenteral nutrition, blood products and specific replacement fluids to replace ongoing insensible or fluid losses from other sites (e.g., fistula losses from the gastrointestinal tract, urinary losses from diabetes insipidus or the polyuric phase of acute renal failure or to correct metabolic derangements).
  • The ICU clinician considers that both 6% hydroxyethyl starch (130/0.4) and saline are equally appropriate for the patient and that no specific indication or contraindication for either exists.
  • The requirement for fluid resuscitation must be supported by AT LEAST ONE of the following clinical signs:

    1. Heart rate > 90 beats per minute
    2. Systolic blood pressure (SBP) < 100mmHg or mean arterial pressure (MAP) < 75mmHg or at least 40mmHg decrease in SBP or MAP from the baseline recording
    3. Central venous pressure < 10mmHg
    4. Pulmonary artery wedge pressure < 12 mmHg
    5. Respiratory variation in systolic or mean arterial blood pressure of >5 mmHg
    6. Capillary refill time > one second
    7. Urine output < 0.5 ml/kg for one hour

Exclusion Criteria:

  • Previous allergic reaction to hydroxyethyl starch solution.
  • Primary non-traumatic intracranial haemorrhage or severe traumatic intracranial haemorrhage (mass lesion > 25 ml).
  • Patients who are receiving renal replacement therapy or in whom the ICU physician considers renal replacement therapy is imminent (i.e. renal replacement therapy will start in 6 hours)
  • Patients with documented serum creatinine value ≥ 350µmol/L and urine output averaging ≤ 10ml / hr over 12 hours
  • Severe hypernatraemia (Serum sodium > 160 mmol/l) or severe hyperchloraemia (Serum chloride > 130 mmol/l).
  • Women of child bearing age (18-49 years old), unless evidence of documented menopause, hysterectomy or surgical sterilisation or negative pregnancy test before randomisation
  • Breastfeeding
  • Patients who have received > 1000mL hydroxyethyl starch in the 24 hours before randomization.
  • Patients admitted to the ICU following cardiac surgery; patients admitted to ICU following cardiac surgery.
  • Patients admitted to the ICU for the treatment of burns or following liver transplantation surgery.
  • Death is deemed imminent and inevitable or the patient has an underlying disease process with a life expectancy of < 90 days.
  • A limitation of therapy order has been documented restricting implementation of the study protocol or the treating clinician deems aggressive care unsuitable.
  • Patient has previously been enrolled in the CHEST study.
  • Patient has previously received fluid resuscitation that was prescribed within the study ICU during this current ICU admission.
  • Patient has been transferred to the study ICU from another ICU and received fluid resuscitation for the treatment of volume depletion in that other ICU.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00935168
GI-CCT24378, ACTRN12609000245291
Yes
The George Institute
The George Institute
  • University of Sydney
  • Australian and New Zealand Intensive Care Society Clinical Trials Group
  • Fresenius Kabi
Study Chair: John A Myburgh, PhD FJFICM The George Institute
Principal Investigator: Simon Finfer Royal North Shore Hospital, NSW, Australia
Principal Investigator: David Gattas Royal Prince Alfred Hospital, NSW, Australia
Principal Investigator: Eddie Stachowski Westmead Hospital, NSW, Australia
Principal Investigator: Michael Parr Liverpool Hospital, NSW, Australia
Principal Investigator: Ian Seppelt Nepean Hospital, NSW, Australia
Principal Investigator: Peter Harrigan John Hunter Hospital, NSW, Australia
Principal Investigator: Rinaldo Bellomo Austin Hospital, VIC, Australia
Principal Investigator: Forbes McGain Western Hospital, VIC, Australia
Principal Investigator: Rob Boots Royal Brisbane & Women's Hospital, QLD, Australia
Principal Investigator: Jason Fletcher Bendigo Health, VIC, Australia
Principal Investigator: David Milliss Concord Hospital, NSW, Australia
Principal Investigator: Benno Ihle Epworth Richmond, VIC, Australia
Principal Investigator: David Ernest Box Hill Hospital, VIC, Australia
Principal Investigator: Jeffrey Presneill Mater Health Services, QLD, Australia
Principal Investigator: Claire Cattigan Geelong Hospital, VIC, Australia
Principal Investigator: Katrina Ellem Calvary Mater Newcastle, NSW, Australia
Principal Investigator: Seton Henderson Christchurch Hospital, New Zealand
Principal Investigator: Shay McGuinness Auckland CVICU, New Zealand
Principal Investigator: Dick Dinsdale Wellington Hospital, New Zealand
Principal Investigator: Michael Reade The Northen Hospital, VIC, Australia
Principal Investigator: Bart de Keulenaer Fremantle Hospital, WA, Australia
Principal Investigator: Latesh Poojara Blacktown Hospital, NSW, Australia
Principal Investigator: Yahya Shehabi Prince of Wales Hospital, NSW, Australia
Principal Investigator: Imogen Mitchell The Canberra Hospital, ACT, Australia
Principal Investigator: John Santamaria St Vincent's Hospital, VIC, Australia
Principal Investigator: Troy Browne Tauranga Hospital, New Zealand
Principal Investigator: Kavi Haji Frankston Hospital, VIC Australia
Principal Investigator: Frank van Haren Waikato Hospital, New Zealand
Principal Investigator: Janet Liang North Shore Hospital, New Zealand
Principal Investigator: Bala Venkatesh Wesley Hospital, VIC, Australia
Principal Investigator: David Cooper Royal Hobart Hospital, TAS, Australia
Principal Investigator: John Myburgh St George Hospital, NSW, Australia
The George Institute
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP