Early Goal Directed Therapy for Acute Kidney Injury

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00306059
• Collaborator: (none)
• Enrollment: 340
• Location: 1
• Arm: 1
• Duration (Months): 29.9
• Patients Per Site Per Month: 11.4

Study Details

Study Description

Brief Summary

Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury

Condition or Disease	Intervention/Treatment	Phase
Kidney Injury, Acute	Procedure: Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 340 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Goal Directed Therapy for Acute Kidney Injury
• Study Start Date: Jan 1, 2013
• Anticipated Primary Completion Date: Jul 1, 2015
• Anticipated Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patients having acute kidney injury	Procedure: Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury; Directed therapy during 6 hours after occurence of the early phase of acute kidney injury.

Outcome Measures

Primary Outcome Measures

1. Observation of acute kidney injury [after 48 hours]

Secondary Outcome Measures

1. Organ failure during first 48 hours and during stay on intensive care unit [after 48 hours]

2. Duration of stay on intensive care unit and in hospital [t0]

3. Mortality during stay on intensive care unit [after 28 days, 60 days and during stay in hospital]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• over 18 years old

• occurence of the early phase of acute kidney injury

• stay on intensive care unit

Exclusion Criteria:

• chronic haemodialysis

• not given informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Eric Hoste, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website University Hospital Ghent

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT00306059
• Other Study ID Numbers: 2006/096
• First Posted: Mar 22, 2006
• Last Update Posted: Dec 5, 2014
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Acute Kidney Injury; Wounds and Injuries

Study Results

No Results Posted as of Dec 5, 2014