Chloride High Level Of Resuscitation Infusion Chloride High Level Of Resuscitation Infusion Delivered Evaluation (CHLORIDE)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Austin Health.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Austin Health
Information provided by:
Austin Health
ClinicalTrials.gov Identifier:
NCT00885404
First received: April 21, 2009
Last updated: February 24, 2010
Last verified: February 2010
| Tracking Information | |||||
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| First Received Date ICMJE | April 21, 2009 | ||||
| Last Updated Date | February 24, 2010 | ||||
| Start Date ICMJE | February 2009 | ||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Mean base excess during hospital stay [ Time Frame: Six month control period (before) and 6 month intervention period (after) ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00885404 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Chloride High Level Of Resuscitation Infusion Chloride High Level Of Resuscitation Infusion Delivered Evaluation | ||||
| Official Title ICMJE | 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. | ||||
| Brief 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®). |
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| 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). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Lower chloride fluids (Hartmann's solution and Plasmalyte®)
Intravenous fluids used during the 6 month intervention period (after). Amount of fluids to be used is based on clinicians' discretion.
Other Names:
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| Study Arm (s) | Intravenous fluids
Intervention: Drug: Lower chloride fluids (Hartmann's solution and Plasmalyte®) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 7000 | ||||
| Estimated Completion Date | August 2010 | ||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Nil |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Australia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00885404 | ||||
| Other Study ID Numbers ICMJE | 2008/03445 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Nor'azim Mohd Yunos, Clinical Research Fellow, Department of Intensive Care, Austin Hospital. | ||||
| Study Sponsor ICMJE | Austin Health | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Austin Health | ||||
| Verification Date | February 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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