Optimal Intensity of Renal Replacement Therapy on Sepsis PatientsNCT01251081
Effect of the Intensity of Continuous Renal Replacement Therapy
A study testing extra high volume hemofiltration and high volume hemofiltration in people with Optimal Intensity of Renal Replacement Therapy on Sepsis Patients, run by Zhejiang University at 1 site in China.
Trial summary
In patients with sepsis and AKI, increasing the intensity of renal replacement therapy from 50 mL/kg/h (HVHF) to 85 mL/kg/h (EHVHF)will increase the survival at 28 days and 90 days. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Optimal Intensity of Renal Replacement Therapy on Sepsis Patients
- What is being tested?
- extra high volume hemofiltration and high volume hemofiltration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- Jan 2004to Jun 2010
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- met at least one of the following criteria: oliguria (urine output less than 100 mL in a 6 h period and unresponsive to fluid resuscitation), serum potassium concentration more than 6.5 mmol/L, severe acidemia (pH < 7.2), serum creatinine more than 250 µmol/L, or presence of severe organ edema (e.g. pulmonary edema).
Who cannot join
- were presence of a malignant tumor, chronic renal insufficiency (serum creatinine >133 µmol/L), or receiving any kind of renal replacement therapy before randomization.
Trial locations and contacts
1 site in 1 country.
China1 site
Kidney disease center, the first affiliated hospital, medical college of Zhejiang university
Hangzhou, Zhejiang, 310003
About this study
Official title: Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Sepsis and Acute Kidney Injury: Single-center Randomized Clinical Trial
In patients with sepsis and AKI, increasing the intensity of renal replacement therapy from 50 mL/kg/h (HVHF) to 85 mL/kg/h (EHVHF)will increase the survival at 28 days and 90 days.
- Being tested
- extra high volume hemofiltration, high volume hemofiltration
- Keywords
- high volume hemofiltration, sepsis, acute kidney injury, survival
- Medical subject headings
- Sepsis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extra high volume hemofiltrationOther
extra high volume hemofiltration (85 mL/kg/h, EHVHF)
high volume hemofiltrationOther
high volume hemofiltration (50 mL/kg/h, HVHF)
| Study group | Role | What they receive |
|---|---|---|
| extra high volume hemofiltration | Experimental | extra high volume hemofiltration (85 mL/kg/h, EHVHF) Receives: Other: extra high volume hemofiltration |
| high volume hemofiltration | Sham comparator | high volume hemofiltration (50 mL/kg/h, HVHF) Receives: Other: high volume hemofiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
90 days survival
The primary study outcome was death from any cause within 90 days. Results were analyzed by Kaplan-Meier survival curves
Secondary outcomes (1)
length of stay in the ICU and hospital
Secondary outcomes were length of stay in the ICU and hospital and renal outcome of survivors at 90 days after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startJan 2004
- Primary completionAug 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optimal Intensity of Renal Replacement Therapy on Sepsis PatientsStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Investigators
- jianghua chen, MD, Study director, Kidney disease center, the first affiliated hospital, medical college of Zhejiang university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251081
- Sponsor's protocol ID
- VHVHF
- Status last verified
- Jan 2004
- First submitted
- 30 Nov 2010
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Sepsis and Acute Kidney Injury: Single-center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01251081
- Acronym / sponsor ID
- VHVHF
- Keywords
- high volume hemofiltration, sepsis, acute kidney injury, survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 1 Dec 2010 (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.
In patients with sepsis and AKI, increasing the intensity of renal replacement therapy from 50 mL/kg/h (HVHF) to 85 mL/kg/h (EHVHF)will increase the survival at 28 days and 90 days.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extra high volume hemofiltration | Experimental | Other: extra high volume hemofiltrationextra high volume hemofiltration (85 mL/kg/h, EHVHF) |
| high volume hemofiltration | Sham comparator | Other: high volume hemofiltrationhigh volume hemofiltration (50 mL/kg/h, HVHF) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- met at least one of the following criteria: oliguria (urine output less than 100 mL in a 6 h period and unresponsive to fluid resuscitation), serum potassium concentration more than 6.5 mmol/L, severe acidemia (pH < 7.2), serum creatinine more than 250 µmol/L, or presence of severe organ edema (e.g. pulmonary edema).
Key exclusion criteria (1 listed)
- were presence of a malignant tumor, chronic renal insufficiency (serum creatinine >133 µmol/L), or receiving any kind of renal replacement therapy before randomization.
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 |
|---|---|---|
| extra high volume hemofiltrationextra high volume hemofiltration (85 mL/kg/h, EHVHF) | Other | extra high volume hemofiltration |
| high volume hemofiltrationhigh volume hemofiltration (50 mL/kg/h, HVHF) | Other | high volume hemofiltration |
Primary outcome
90 days survival
The primary study outcome was death from any cause within 90 days. Results were analyzed by Kaplan-Meier survival curves
1 secondary outcome
length of stay in the ICU and hospital
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 1 Dec 2010.
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.
jianghua chen, MD study director
Kidney disease center, the first affiliated hospital, medical college of Zhejiang university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extra high volume hemofiltration and high volume hemofiltration in people with Optimal Intensity of Renal Replacement Therapy on Sepsis Patients, run by Zhejiang University at 1 site in China.
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 1 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 1 Dec 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 China. 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. Some participants in this study may receive a placebo. 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?
90 days survival. 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 1 Dec 2010.