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ShockPhase 4CHLORIDENCT00885404

Chloride High Level Of Resuscitation Infusion Chloride High Level Of Resuscitation Infusion Delivered Evaluation

A Phase 4 study testing Lower chloride fluids (Hartmann's solution and Plasmalyte®) in people with Shock and Critical Illness, run by Austin Health at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether intravenous fluid management using lower chloride solutions (Hartmann's solutions and Plasmalyte®) will result in better outcome when compared to management using high chloride solutions (0.9% saline and Gelofusine®). Read more about this study

Who is it for?
Any age
Conditions the study is for
Shock, Critical Illness
What is being tested?
Lower chloride fluids (Hartmann's solution and Plasmalyte®)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,000 participants
Where
1 siteAustralia
Study dates
Feb 2009to Aug 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All Intensive Care Unit (ICU) admissions at Austin Hospital
  • All Emergency Department (ED) admissions at Austin Hospital
  • All operations at Operating Theatre (OT) with hospital stay of more than 48 hours

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Austin Health

    Melbourne, Victoria, 3084

Other trials in Australia

About this study

Official title: A Prospective, Before and After Study of the Impact of Lower Chloride Intravenous Fluid Management on Patients' Acid-base Status, Renal Profile,Length of Stay and Mortality.

The purpose of this study is to determine whether intravenous fluid management using lower chloride solutions (Hartmann's solutions and Plasmalyte®) will result in better outcome when compared to management using high chloride solutions (0.9% saline and Gelofusine®).

Read the detailed description

This is a prospective, controlled, before-and-after study. The baseline pre-intervention period will include collection of data while doctors and nurses are unaware that such collection is taking place. During this time, high chloride fluids (saline, Gelofusine, 4% albumin) will continue to be used according to standard practice with an estimated 30,000 liters of saline as well as 2,000 bottles of Gelofusine® being consumed.

Following a wash out period of education and preparation, there will be a complete shift to a working environment where use of saline, Gelofusine and any other fluids with a high chloride level (>110 mmol/L)will be restricted and substituted with fluids of lower chloride concentration similar to blood; either Hartmann's solution or Plasmalyte® or 20% albumin.

The study will compare a 6 month control period (before) and a six month intervention period (after).

Being tested
Lower chloride fluids (Hartmann's solution and Plasmalyte®)
Keywords
chloride, acidosis
Medical subject headings
Shock, Critical Illness, Acidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lower chloride fluids (Hartmann's solution and Plasmalyte®)Drug

    Also called Plasmalyte, Lactated solution

    Intravenous fluids used during the 6 month intervention period (after). Amount of fluids to be used is based on clinicians' discretion.

Study groups in NCT00885404
Study groupRoleWhat they receive
Intravenous fluidsOtherNot described
Receives: Drug: Lower chloride fluids (Hartmann's solution and Plasmalyte®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean base excess during hospital stay

    Measured: Six month control period (before) and 6 month intervention period (after)

Secondary outcomes (6)

  1. Unmeasured anions (strong ion gap) and chloride levels during hospital stay

    Measured: Six month control period (before) and 6 month intervention period (after)

  2. Serum creatine levels

    Measured: Six month control period (before) and 6 month intervention period (after)

  3. Length of ICU stay

    Measured: Six month control period (before) and 6 month intervention period (after)

  4. Length of Emergency Department stay

    Measured: Six month control period (before) and 6 month intervention period (after)

  5. Length of hospital stay

    Measured: Six month control period (before) and 6 month intervention period (after)

  6. In-hospital mortality

    Measured: Six month control period (before) and 6 month intervention period (after)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionAug 2009 (estimated)
  4. Study completionAug 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
7,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00885404
Sponsor's protocol ID
2008/03445
Other IDs
2008
Acronym
CHLORIDE
Status last verified
Feb 2010
First submitted
21 Apr 2009
Last updated
25 Feb 2010
Results posted
No
Data monitoring committee
No

Publications

  • Stewart PA. How to understand acid-base. A Quantitative Primer for Biology and Medicine. New York: Elsevier, 1981.

  • Stewart PA. Modern quantitative acid-base chemistry. Can J Physiol Pharmacol. 1983 Dec;61(12):1444-61. doi: 10.1139/y83-207.

    PubMed 6423247

  • Sirker AA, Rhodes A, Grounds RM, Bennett ED. Acid-base physiology: the 'traditional' and the 'modern' approaches. Anaesthesia. 2002 Apr;57(4):348-56. doi: 10.1046/j.0003-2409.2001.02447.x.

    PubMed 11939993

  • Constable PD. Hyperchloremic acidosis: the classic example of strong ion acidosis. Anesth Analg. 2003 Apr;96(4):919-922. doi: 10.1213/01.ANE.0000053256.77500.9D. No abstract available.

    PubMed 12651634

  • Dorje P, Adhikary G, McLaren ID, Bogush S. Dilutional acidosis or altered strong ion difference. Anesthesiology. 1997 Oct;87(4):1011-2; author reply 1013-4. doi: 10.1097/00000542-199710000-00052. No abstract available.

    PubMed 9357917

  • Story DA, Liskaser F, Bellomo R. Saline infusion, acidosis, and the Stewart approach. Anesthesiology. 2000 Feb;92(2):624; author reply 626. doi: 10.1097/00000542-200002000-00053. No abstract available.

    PubMed 10691256

  • Story DA, Poustie S, Bellomo R. Quantitative physical chemistry analysis of acid-base disorders in critically ill patients. Anaesthesia. 2001 Jun;56(6):530-3. doi: 10.1046/j.1365-2044.2001.01983.x.

    PubMed 11412158

  • Reid F, Lobo DN, Williams RN, Rowlands BJ, Allison SP. (Ab)normal saline and physiological Hartmann's solution: a randomized double-blind crossover study. Clin Sci (Lond). 2003 Jan;104(1):17-24.

    PubMed 12519083

  • Dorje P, Adhikary G, Tempe DK. Avoiding latrogenic hyperchloremic acidosis--call for a new crystalloid fluid. Anesthesiology. 2000 Feb;92(2):625-6. doi: 10.1097/00000542-200002000-00055. No abstract available.

    PubMed 10691258

  • Morgan TJ, Venkatesh B, Hall J. Crystalloid strong ion difference determines metabolic acid-base change during in vitro hemodilution. Crit Care Med. 2002 Jan;30(1):157-60. doi: 10.1097/00003246-200201000-00022.

    PubMed 11902256

  • Kellum JA. Fluid resuscitation and hyperchloremic acidosis in experimental sepsis: improved short-term survival and acid-base balance with Hextend compared with saline. Crit Care Med. 2002 Feb;30(2):300-5. doi: 10.1097/00003246-200202000-00006.

    PubMed 11889298

  • Morgan TJ, Venkatesh B, Hall J. Crystalloid strong ion difference determines metabolic acid-base change during acute normovolaemic haemodilution. Intensive Care Med. 2004 Jul;30(7):1432-7. doi: 10.1007/s00134-004-2176-x. Epub 2004 Feb 28.

    PubMed 14991093

  • Story DA, Morimatsu H, Bellomo R. Hyperchloremic acidosis in the critically ill: one of the strong-ion acidoses? Anesth Analg. 2006 Jul;103(1):144-8, table of contents. doi: 10.1213/01.ane.0000221449.67354.52.

    PubMed 16790643

  • Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.

    PubMed 23073953

  • Yunos NM, Kim IB, Bellomo R, Bailey M, Ho L, Story D, Gutteridge GA, Hart GK. The biochemical effects of restricting chloride-rich fluids in intensive care. Crit Care Med. 2011 Nov;39(11):2419-24. doi: 10.1097/CCM.0b013e31822571e5.

    PubMed 21705897

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lower chloride fluids (Hartmann's solution and Plasmalyte®) in people with Shock and Critical Illness, run by Austin Health at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean base excess during hospital stay (time frame: Six month control period (before) and 6 month intervention period (after)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00885404, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2010.

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