Acute Kidney InjuryNCT00971971
Prevention of Intradialytic Hypotension in Acute Kidney Injury Patients
A study testing Dialysis and Standard SLED in people with Acute Kidney Injury and Acute Renal Failure, run by Sao Jose do Rio Preto Medical School at 1 site in Brazil.
Trial summary
Intradialytic hypotension (IH) is a major complication during acute hemodialysis. The aim of this study was to evaluate the effects of dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling on hemodynamics of critically ill acute kidney injury (AKI) patients submitted to sustained… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Acute Renal Failure
- What is being tested?
- Dialysis and Standard SLED
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2005to Sep 2009
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute renal failure with a need of dialysis.
Who cannot join
- Patients with basal serum creatinine > 3 mgdL.
- Patients submitted to renal transplantation.
- Patients unlikely to survive.
- Declination in authorization to participation in the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
São Jose do Rio Preto Medical School
São José do Rio Preto, São Paulo, 15090-000
About this study
Official title: Assessment of a Protocol Aiming to Prevent Intradialytic Hypotension in Critically Ill Acute Kidney Injury Patients
Intradialytic hypotension (IH) is a major complication during acute hemodialysis. The aim of this study was to evaluate the effects of dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling on hemodynamics of critically ill acute kidney injury (AKI) patients submitted to sustained low-efficiency dialysis (SLED).
- Conditions
- Acute Kidney Injury, Acute Renal Failure
- Being tested
- Dialysis, Standard SLED
- Keywords
- Hypotension, Acute renal failure, acute kidney injury, dialysis, ICU
- Medical subject headings
- Acute Kidney Injury, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DialysisProcedure or surgery
dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling
Standard SLEDProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Traditional SLED Receives: Procedure: Standard SLED |
| Profiling | Experimental | dialysate temperature reduction with Na and ultrafiltration (UF) profiling Receives: Procedure: Dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intradialytic hypotension
Measured: At dialysis session
Secondary outcomes (1)
Dialysis dose
Measured: dialysis session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startOct 2005
- Primary completionJul 2007
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sao Jose do Rio Preto Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971971
- Sponsor's protocol ID
- 10727-6
- Status last verified
- Sep 2009
- First submitted
- 3 Sep 2009
- Last updated
- 7 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Protocol Aiming to Prevent Intradialytic Hypotension in Critically Ill Acute Kidney Injury Patients
- ClinicalTrials.gov ID
- NCT00971971
- Acronym / sponsor ID
- 10727-6
- Conditions
- Acute Kidney Injury, Acute Renal Failure
- Keywords
- Hypotension, Acute renal failure, acute kidney injury, dialysis, ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sao Jose do Rio Preto Medical SchoolUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Oct 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intradialytic hypotension (IH) is a major complication during acute hemodialysis. The aim of this study was to evaluate the effects of dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling on hemodynamics of critically ill acute kidney injury (AKI) patients submitted to sustained low-efficiency dialysis (SLED).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | Procedure: Standard SLEDTraditional SLED |
| Profiling | Experimental | Procedure: Dialysisdialysate temperature reduction with Na and ultrafiltration (UF) profiling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute renal failure with a need of dialysis.
Key exclusion criteria (4 listed)
- Patients with basal serum creatinine > 3 mgdL.
- Patients submitted to renal transplantation.
- Patients unlikely to survive.
- Declination in authorization to participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialysisdialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling | Procedure or surgery | Profiling |
| Standard SLED | Procedure or surgery | Control |
Primary outcome
Intradialytic hypotension
Time frame: At dialysis session
1 secondary outcome
Dialysis dose
Time frame: dialysis session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2009.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialysis and Standard SLED in people with Acute Kidney Injury and Acute Renal Failure, run by Sao Jose do Rio Preto Medical School at 1 site in Brazil.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 7 Sep 2009. 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 Brazil. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intradialytic hypotension (time frame: At dialysis session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2009.