HypoalbuminemiaNCT03675906
The Relationship Between Hypoalbuminemia and Development of Acute Kidney Failure (AKI) According to KDIGO Criteria
An observational study of Hypoalbuminemia and Acute Kidney Failure, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to determine the association between preoperative and postoperative hypoalbuminemia and AKI in older age hip fracture surgeons, to determine which period of hypoalbuminemia contributes more to AKI development, the incidence of AKI according to anesthesia type, the presence of other factors… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypoalbuminemia, Acute Kidney Failure
- What is being tested?
- hypoalbuminemia
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Sep 2018to 30 Dec 2018
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: ASA I - IV physical status and under spinal anesthesia or peripheric nerve block, 160 patients over 65 years of age undergoing femoral fracture surgery between 01.01.2018 - 01.07.2018
Who may be able to join
- patients with femur fracture surgery
- 65 years and over
- Patients with ASA I - IV physical condition
- patients with spinal anesthesia or peripheral nerve block
Who cannot join
- Patients undergoing emergency surgery
- patients with preoperative serum creatinine (sCr) level> 1.5 mg / dl
- patients with low serum albumin levels in both preoperative and postoperative periods
- patients receiving preoperative ventilator care
- patients with spinal anesthesia or peripheral nerve block contraindications (coagulopathies, local infection at the puncture site, spot infection) or nonsteroidal antiinflammatory drug (NSAID)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Preoperative and Postoperative Hypoalbuminemia and Development of Acute Kidney Failure (AKI) According to KDIGO Criteria in Advanced Age Hip Kidney Surgery
This study was designed to determine the association between preoperative and postoperative hypoalbuminemia and AKI in older age hip fracture surgeons, to determine which period of hypoalbuminemia contributes more to AKI development, the incidence of AKI according to anesthesia type, the presence of other factors affecting AKI development, the duration of hospitalization and cost- to be investigated.
- Conditions
- Hypoalbuminemia, Acute Kidney Failure
- Being tested
- hypoalbuminemia
- Keywords
- hypoalbuminemia, Acute Kidney Failure, older age, hip fracture
- Medical subject headings
- Hypoalbuminemia, Acute Kidney Injury, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypoalbuminemiaOther
hypoalbuminemia and acute kidney injury
| Study group | Role | What they receive |
|---|---|---|
| preoperative albumin levels <3.8 | Not described Receives: Other: hypoalbuminemia | |
| preoperative albumin level >3.8 | Not described Receives: Other: hypoalbuminemia | |
| postoperative Day 2 albumin level <2.9 | Not described Receives: Other: hypoalbuminemia | |
| postoperative Day 2 albumin level >2.9 | Not described Receives: Other: hypoalbuminemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypoalbuminemia and AKI - incidence of AKI
hypoalbuminemia and incidence of AKI according to KDIGO criterias
Measured: 3 months
Secondary outcomes (1)
anesthesia type - incidence of AKI
incidence of AKI according to anesthesia type
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start12 Sep 2018
- Primary completion15 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypoalbuminemiaStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675906
- Sponsor's protocol ID
- ERZINCAN BINALI YILDIRIM
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Section 2: AKI Definition. Kidney Int Suppl (2011). 2012 Mar;2(1):19-36. doi: 10.1038/kisup.2011.32. No abstract available.
PubMed 25018918Kim HJ, Koh WU, Kim SG, Park HS, Song JG, Ro YJ, Yang HS. Early postoperative albumin level following total knee arthroplasty is associated with acute kidney injury: A retrospective analysis of 1309 consecutive patients based on kidney disease improving global outcomes criteria. Medicine (Baltimore). 2016 Aug;95(31):e4489. doi: 10.1097/MD.0000000000004489.
PubMed 27495094Kim K, Bang JY, Kim SO, Kim S, Kim JU, Song JG. Association of preoperative hypoalbuminemia with postoperative acute kidney injury in patients undergoing brain tumor surgery: a retrospective study. J Neurosurg. 2018 Apr;128(4):1115-1122. doi: 10.3171/2016.11.JNS162237. Epub 2017 May 5.
PubMed 28474996Shin KH, Han SB. Early postoperative hypoalbuminemia is a risk factor for postoperative acute kidney injury following hip fracture surgery. Injury. 2018 Aug;49(8):1572-1576. doi: 10.1016/j.injury.2018.05.001. Epub 2018 May 2.
PubMed 29908852
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Preoperative and Postoperative Hypoalbuminemia and Development of Acute Kidney Failure (AKI) According to KDIGO Criteria in Advanced Age Hip Kidney Surgery
- ClinicalTrials.gov ID
- NCT03675906
- Acronym / sponsor ID
- ERZINCAN BINALI YILDIRIM
- Conditions
- Hypoalbuminemia, Acute Kidney Failure
- Keywords
- hypoalbuminemia, Acute Kidney Failure, older age, hip fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 18 Sep 2018 (actual)
- 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.
This study was designed to determine the association between preoperative and postoperative hypoalbuminemia and AKI in older age hip fracture surgeons, to determine which period of hypoalbuminemia contributes more to AKI development, the incidence of AKI according to anesthesia type, the presence of other factors affecting AKI development, the duration of hospitalization and cost- to be investigated.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| preoperative albumin levels <3.8 | – | Other: hypoalbuminemia |
| preoperative albumin level >3.8 | – | Other: hypoalbuminemia |
| postoperative Day 2 albumin level <2.9 | – | Other: hypoalbuminemia |
| postoperative Day 2 albumin level >2.9 | – | Other: hypoalbuminemia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- ASA I - IV physical status and under spinal anesthesia or peripheric nerve block, 160 patients over 65 years of age undergoing femoral fracture surgery between 01.01.2018 - 01.07.2018
Key inclusion criteria (4 listed)
- patients with femur fracture surgery
- 65 years and over
- Patients with ASA I - IV physical condition
- patients with spinal anesthesia or peripheral nerve block
Key exclusion criteria (5 listed)
- Patients undergoing emergency surgery
- patients with preoperative serum creatinine (sCr) level> 1.5 mg / dl
- patients with low serum albumin levels in both preoperative and postoperative periods
- patients receiving preoperative ventilator care
- patients with spinal anesthesia or peripheral nerve block contraindications (coagulopathies, local infection at the puncture site, spot infection) or nonsteroidal antiinflammatory drug (NSAID)
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 |
|---|---|---|
| hypoalbuminemiahypoalbuminemia and acute kidney injury | Other | postoperative Day 2 albumin level <2.9, postoperative Day 2 albumin level >2.9, preoperative albumin level >3.8, preoperative albumin levels <3.8 |
Primary outcome
hypoalbuminemia and AKI - incidence of AKI
Time frame: 3 months
hypoalbuminemia and incidence of AKI according to KDIGO criterias
1 secondary outcome
anesthesia type - incidence of AKI
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Results publication: PubMed 25018918Section 2: AKI Definition. Kidney Int Suppl (2011). 2012 Mar;2(1):19-36. doi: 10.1038/kisup.2011.32. No abstract available.
- Results publication: PubMed 27495094Kim HJ, Koh WU, Kim SG, Park HS, Song JG, Ro YJ, Yang HS. Early postoperative albumin level following total knee arthroplasty is associated with acute kidney injury: A retrospective analysis of 1309 consecutive patients based on kidney disease improving global outcomes criteria. Medicine (Baltimore). 2016 Aug;95(31):e4489. doi: 10.1097/MD.0000000000004489.
- Results publication: PubMed 28474996Kim K, Bang JY, Kim SO, Kim S, Kim JU, Song JG. Association of preoperative hypoalbuminemia with postoperative acute kidney injury in patients undergoing brain tumor surgery: a retrospective study. J Neurosurg. 2018 Apr;128(4):1115-1122. doi: 10.3171/2016.11.JNS162237. Epub 2017 May 5.
- Results publication: PubMed 29908852Shin KH, Han SB. Early postoperative hypoalbuminemia is a risk factor for postoperative acute kidney injury following hip fracture surgery. Injury. 2018 Aug;49(8):1572-1576. doi: 10.1016/j.injury.2018.05.001. Epub 2018 May 2.
- Individual participant dataSharing planned: No
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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?
An observational study of Hypoalbuminemia and Acute Kidney Failure, run by Erzincan University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 18 Sep 2018. 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 Turkey (Türkiye). 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?
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?
hypoalbuminemia and AKI - incidence of AKI (time frame: 3 months). 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 NCT03675906, which also lists 4 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 18 Sep 2018.