Chronic Kidney Disease Stage VNCT06611189
A Comparative Analysis of Ray-Tech Sponge and Ice Bag Techniques in Kidney Transplantation
An observational study of Chronic Kidney Disease Stage V, run by Okan University at 2 sites in Turkey (Türkiye).
Trial summary
Warm ischemia during kidney transplantation is one of the important factors that negatively affect kidney function in the recipient. The investigators aimed to examine the effects of two techniques (Ray-Tech sponge technique and Ice bag technique) applied to protect the kidney from warm ischemia during kidney… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease Stage V
- What is being tested?
- surgery and Ray-Tech sponge technique
- How many people
- 172 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Jan 2025
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All individuals were selected from those who underwent Kidney transplantation at our institution between January 2020 and January 2023.
Who may be able to join
- -Underwent kidney transplantation surgery
Who cannot join
- Deceased donor transplantation
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Murat Ferhat Ferhatoglu
Istanbul, Kadıköy, 34734
Istanbul Okan University
Istanbul, 34334
About this study
Official title: A Comparative Analysis of Ray-Tech Sponge and Ice Bag Techniques in the Elimination of Warm Ischemic Time in Kidney Transplantation
Warm ischemia during kidney transplantation is one of the important factors that negatively affect kidney function in the recipient. The investigators aimed to examine the effects of two techniques (Ray-Tech sponge technique and Ice bag technique) applied to protect the kidney from warm ischemia during kidney transplantation on long-term kidney function.
Read the detailed description
A prospective, randomized clinical trial was conducted at Istanbul Okan University Hospital, Istanbul, Turkey. All participants were selected from those who underwent kidney transplantation between January 2020 and January 2023.
- Conditions
- Chronic Kidney Disease Stage V
- Being tested
- surgery, Ray-Tech sponge technique
- Keywords
- Kidney transplantation, Warm ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryOther
Also called Simple plastic bag to preserve kidney from warm ischemia
In order to preserve kidney from warm ischemia during graft implantation, on the back table, graft were prepared for implantation with standard techniques. The kidney was introduced into the bag which was filled with a small amount of ice and preservation fluid (Figure 1). After inplacement of the graft, a small hole was made near the hilum and the renal artery and vein were passed through the hole. A Kocher clamp was used to maintain the fluid and ice in place and as a handle. Also, a Hartman Mosquito Clamp was used to mark urether-side, and to maintain orientation.
Ray-Tech sponge techniqueOther
On the back table, graft were prepared for implantation with standard techniques. A Raytech sponge is soaked in ice-cold preservative solution, and wrapped around the kidney and held with a clamp (Figure 2). Position and oriantation of the graft was done by direct vision of urether.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Kidney transplantation performed using the ice bag technique. Receives: Other: surgery | |
| Group B | Kidney transplantation performed using Raytech sponge technique. Receives: Other: Ray-Tech sponge technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine decrease
Serum creatinine levels at 7th, 30th, 60th, and 180th days after operation were evaluated
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Jan 2020
- Primary completion1 Jan 2023
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Stage VStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Ferhat Ferhatoglu, Okan University
- Investigators
- MURAT F FERHATOGLU, MD, Principal investigator, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611189
- Sponsor's protocol ID
- No: 161, Date: December 14, 20
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing data is not right in terms of patient privacy. When the informed consent form was signed by participants, only information about the study was given. No information was given about data sharing.
Publications
Ferede AA, Walsh AL, Davis NF, Smyth G, Mohan P, Power R, Forde J, O'Kelly P, Llittle D. Warm Ischemia Time at Vascular Anastomosis is an Independent Predictor for Delayed Graft Function in Kidney Transplant Recipients. Exp Clin Transplant. 2020 Feb;18(1):13-18. doi: 10.6002/ect.2018.0377. Epub 2019 Jul 2.
PubMed 31266437Ide K, Sakai H, Nakano R, Imaoka Y, Tanimine N, Ide R, Tsukiyama N, Ono K, Mochizuki T, Arata R, Hakoda K, Imaoka K, Fukuhara S, Bekki T, Tahara H, Ohira M, Kobayashi E, Ohdan H. Effectiveness of Thermal Barrier Bag for Prolonged Vascular Anastomosis in Kidney Transplantation. Transplant Proc. 2023 May;55(4):752-755. doi: 10.1016/j.transproceed.2023.03.004. Epub 2023 Apr 6.
PubMed 37028949Ide K, Nakano R, Imaoka Y, Sakai H, Ono K, Tanimine N, Tahara H, Ohira M, Ueda K, Hirata T, Kobayashi E, Ohdan H. Protection From Second Warm Ischemic Injury Using a Thermal Barrier Bag in Kidney Transplantation. Transplant Direct. 2023 Feb 17;9(3):e1454. doi: 10.1097/TXD.0000000000001454. eCollection 2023 Mar.
PubMed 36845857
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of Ray-Tech Sponge and Ice Bag Techniques in the Elimination of Warm Ischemic Time in Kidney Transplantation
- ClinicalTrials.gov ID
- NCT06611189
- Acronym / sponsor ID
- No: 161, Date: December 14, 20
- Conditions
- Chronic Kidney Disease Stage V
- Keywords
- Kidney transplantation, Warm ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 24 Sep 2024 (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.
Warm ischemia during kidney transplantation is one of the important factors that negatively affect kidney function in the recipient. The investigators aimed to examine the effects of two techniques (Ray-Tech sponge technique and Ice bag technique) applied to protect the kidney from warm ischemia during kidney transplantation on long-term kidney function.
Detailed description
A prospective, randomized clinical trial was conducted at Istanbul Okan University Hospital, Istanbul, Turkey. All participants were selected from those who underwent kidney transplantation between January 2020 and January 2023.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: surgeryKidney transplantation performed using the ice bag technique. |
| Group B | – | Other: Ray-Tech sponge techniqueKidney transplantation performed using Raytech sponge technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals were selected from those who underwent Kidney transplantation at our institution between January 2020 and January 2023.
Key inclusion criteria (1 listed)
- -Underwent kidney transplantation surgery
Key exclusion criteria (1 listed)
- Deceased donor transplantation
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 |
|---|---|---|
| surgeryAlso: Simple plastic bag to preserve kidney from warm ischemiaIn order to preserve kidney from warm ischemia during graft implantation, on the back table, graft were prepared for implantation with standard techniques. The kidney was introduced into the bag which was filled with a small amount of ice and preservation fluid (Figure 1). After inplacement of the graft, a small hole was made near the hilum and the renal artery and vein were passed through the hole. A Kocher clamp was used to maintain the fluid and ice in place and as a handle. Also, a Hartman Mosquito Clamp was used to mark urether-side, and to maintain orientation. | Other | Group A |
| Ray-Tech sponge techniqueOn the back table, graft were prepared for implantation with standard techniques. A Raytech sponge is soaked in ice-cold preservative solution, and wrapped around the kidney and held with a clamp (Figure 2). Position and oriantation of the graft was done by direct vision of urether. | Other | Group B |
Primary outcome
Creatinine decrease
Time frame: 6 months
Serum creatinine levels at 7th, 30th, 60th, and 180th days after operation were evaluated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Background: PubMed 31266437Ferede AA, Walsh AL, Davis NF, Smyth G, Mohan P, Power R, Forde J, O'Kelly P, Llittle D. Warm Ischemia Time at Vascular Anastomosis is an Independent Predictor for Delayed Graft Function in Kidney Transplant Recipients. Exp Clin Transplant. 2020 Feb;18(1):13-18. doi: 10.6002/ect.2018.0377. Epub 2019 Jul 2.
- Background: PubMed 37028949Ide K, Sakai H, Nakano R, Imaoka Y, Tanimine N, Ide R, Tsukiyama N, Ono K, Mochizuki T, Arata R, Hakoda K, Imaoka K, Fukuhara S, Bekki T, Tahara H, Ohira M, Kobayashi E, Ohdan H. Effectiveness of Thermal Barrier Bag for Prolonged Vascular Anastomosis in Kidney Transplantation. Transplant Proc. 2023 May;55(4):752-755. doi: 10.1016/j.transproceed.2023.03.004. Epub 2023 Apr 6.
- Background: PubMed 36845857Ide K, Nakano R, Imaoka Y, Sakai H, Ono K, Tanimine N, Tahara H, Ohira M, Ueda K, Hirata T, Kobayashi E, Ohdan H. Protection From Second Warm Ischemic Injury Using a Thermal Barrier Bag in Kidney Transplantation. Transplant Direct. 2023 Feb 17;9(3):e1454. doi: 10.1097/TXD.0000000000001454. eCollection 2023 Mar.
- Individual participant dataSharing planned: No. Sharing data is not right in terms of patient privacy. When the informed consent form was signed by participants, only information about the study was given. No information was given about data sharing.
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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.
MURAT F FERHATOGLU, MD principal investigator
Okan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease Stage V, run by Okan University at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Creatinine decrease (time frame: 6 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 NCT06611189, which also lists 3 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 24 Sep 2024.