End Stage Renal DiseasePhase 4BICATHNCT04054128

Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients

A Phase 4 study testing Sodium Bicarbonate 7.5% Injection and Heparin Sodium, 1000 Units/mL Injectable Solution 1 in people with End Stage Renal Disease and Vascular Access Complication, run by Hospital General "Dr. Miguel Silva" de Morelia at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Prospective clinical trial to evaluate the efficacy of catheter lock with bicarbonate vs heparin in chronic hemodialysis patients. Two groups will be created, sodium bicarbonate lock group (experimental group) and heparin lock group (control group). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: End Stage Renal Disease, Vascular Access Complication, Catheter Complications
What is being tested?: Sodium Bicarbonate 7.5% Injection and Heparin Sodium, 1000 Units/mL Injectable Solution 1
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteMexico
Study dates: 11 Sep 2019to 28 Sep 2020
Phase: Phase 4
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who accept participation and sign informed consent.
Incident or prevalent chronic hemodialysis patients who receive at least 2 sessions per week with 1 month of clinical stability defined as: no hospitalizations, no vascular access infections, no changes in blood flow prescription due to vascular access dysfunction.
Patients with temporal catheter (Niagra 13.5 French/20 cm length, BARD Access System, Salt Lake City, Utah, USA) as vascular access for hemodialysis.

Who cannot join

Catheter dysfunction at baseline
On anticoagulation therapy
Patients with known coagulopathy or hemophilia
Patients with Child-Pugh B or C liver failure
Patients with thrombocytopenia less than 100,000 u / L
Patients with central vessel stenosis and vena cava syndrome, previously documented.

Show all 9Show fewer

Patients with vascular access exhaustion.
Patients who have undergone more than 2 vascular approaches for hemodialysis catheters.
Patients with heparin-induced thrombocytopenia

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Hospital General "Dr. Miguel Silva" de Morelia
Morelia, Michoacán, 58020

Other trials in Mexico

About this study

Read the detailed description

A prospective, randomized, clinical, open-label trial at Hospital General "Dr. Miguel Silva" de Morelia, Mexico.

The study period will be between august 16, 2019 to November 16, 2019. The aim of this study is to evaluate the efficacy of catheter lock with bicarbonate vs heparin in chronic hemodialysis patients. Primary outcome will be catheter function. Secondary outcomes will be Infectious complications, thrombotic complications, and frequency of adverse effects between groups.

All patients provided written informed consent before enrollment. The trial protocol was approved by Hospital General "Dr. Miguel Silva" Internal Review Board, register number 17-CI-16053153, and Research \& Ethics committee, with register number 16-CEI-004-20161212, Study registry # 479/01/9.

Patients between 18-65 years old, incident or prevalent chronic hemodialysis, with 1 month of clinical stability and with temporal catheter as vascular access for hemodialysis are eligible. A total of 60 patients will be included in the study. All patients will be randomly assigned into one of two groups: SBCL (n=30), intervention group and HCL (n=30), as control group.

Before each hemodialysis treatment, catheters and connections will be inspected for leaks, evidence of damage, exit-site infection and tunnel infection. Intraluminal SBCL or HCL solution will be removed before connecting the hemodialysis catheter to a dialysis machine prior to any treatment.

During each treatment, patients will be prescribed and monitored for complications and standard treatment will be provided to every patient. After each treatment, blood will be rinsed from dialysis lines with 0.9% saline solution back to the patient. Upon the conclusion of treatment, all catheters will be flushed with 10 mL 0.9% saline solution per blood line respectively, after saline flush, catheter lock will be prescribed; SBCL group with 7.5% sodium bicarbonate solution, at a dose of 2 milliliters per lumen, and HCL group with sodium heparin at a concentration of 1000 units per milliliter, at a dose of 2 milliliters per lumen. Catheter exit site dressing changes occurred after each HD treatment.

Niagra 13.5 French/20 cm non tunneled catheter will be the standard vascular access. All central venous catheters will be inserted by an expert operator under strict aseptic protocol. Catheter care will be performed by trained dialysis staff. At the end of dialysis, all catheters will be flushed and locked with the respectively arm solution.

Function assessment will be based on both, pressure and flow measurements on arterial line, as well as measurements of arterial and venous line pressures and flow during hemodialysis sessions. Infectious and thrombotic complications will be assessed as defined.

Conditions: End Stage Renal Disease, Vascular Access Complication, Catheter Complications, Hemodialysis Access Failure, Hemodialysis Catheter Infection
Being tested: Sodium Bicarbonate 7.5% Injection, Heparin Sodium, 1000 Units/mL Injectable Solution 1
Keywords: Sodium bicarbonate lock, Heparin lock, Vascular access complication
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sodium Bicarbonate 7.5% InjectionDrug
Also called Bicarnat® arm
Sodium bicarbonate solution for catheter lock; 7.5% sodium bicarbonate solution will be used for catheter lock in both catheter lumens, 1.9 mL in each catheter lumen will be infused after hemodialysis treatment during 3 months.
Heparin Sodium, 1000 Units/mL Injectable Solution 1Drug
Also called Inhepar® arm
Heparin for catheter lock: 1000 u/mL heparin solution will be used for catheter lock in both catheter lumens as standard treatment, 1.9 mL in each catheter lumen will be infused after hemodialysis treatment during 3 months.

Study groups in NCT04054128
Study group	Role	What they receive
Sodium bicarbonate catheter lock group (SBCL)	Experimental	Chronic hemodialysis patients with a catheter as a vascular access, will be lock with sodium bicarbonate 7.5% Injection. Receives: Drug: Sodium Bicarbonate 7.5% Injection
Heparin catheter lock group (HCL)	Active comparator	Chronic hemodialysis patients with a catheter as a vascular access, will be lock with heparin, 1000 Units/mL injectable solution Receives: Drug: Heparin Sodium, 1000 Units/mL Injectable Solution 1

What is being measured

The primary outcome is the main question the study is designed to answer.

Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients
Arterial line pressure[mmHg] at 300 mL/min blood flow will be compared between sodium bicarbonate lock and heparin lock in chronic hemodialysis patients.
Measured: 30 days.
Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients
Arterial line pressure[mmHg] at 300 mL/min blood flow will be compared between sodium bicarbonate lock and heparin lock in chronic hemodialysis patients.
Measured: 60 days
Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients
Arterial line pressure[mmHg] at 300 mL/min blood flow will be compared between sodium bicarbonate lock and heparin lock in chronic hemodialysis patients.
Measured: 90 days

Secondary outcomes (3)

Incidence rate of catheter related bloodstream infection
Catheter related bloodstream infection rate (events per 100 days/catheter) will be compare between sodium bicarbonate lock versus heparin lock in chronic hemodialysis patients
Measured: 90 days
Incidence rate of catheter thrombosis
Catheter thrombosis rate (events per 100 days/catheter) will be compare between sodium bicarbonate lock versus heparin lock in chronic hemodialysis patients
Measured: 90 days
Adverse events incidence
To compare the frequency of hemorrhagic event, anaphylaxis, hypernatremia or death between sodium bicarbonate lock vs heparin lock in chronic hemodialysis patients
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 201928 Sep 2020

First posted13 Aug 2019
Study start11 Sep 2019
Primary completion20 Feb 2020
Study completion28 Sep 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for End Stage Renal DiseaseStudies 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Prospective, open label, clinical trial in chronic hemodialysis patients with a catheter as a vascular access, randomized to bicarbonate lock or heparin lock (control) as standard treatment.
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04054128
Sponsor's protocol ID: 479/01/19
Acronym: BICATH
Status last verified: Apr 2020
First submitted: 23 Jul 2019
Last updated: 30 Apr 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jha V, Garcia-Garcia G, Iseki K, Li Z, Naicker S, Plattner B, Saran R, Wang AY, Yang CW. Chronic kidney disease: global dimension and perspectives. Lancet. 2013 Jul 20;382(9888):260-72. doi: 10.1016/S0140-6736(13)60687-X. Epub 2013 May 31.
PubMed 23727169
Ma A, Shroff R, Hothi D, Lopez MM, Veligratli F, Calder F, Rees L. A comparison of arteriovenous fistulas and central venous lines for long-term chronic haemodialysis. Pediatr Nephrol. 2013 Feb;28(2):321-6. doi: 10.1007/s00467-012-2318-2. Epub 2012 Oct 6.
PubMed 23052655
Adib-Hajbaghery M, Molavizadeh N, Alavi NM. Quality of care of vascular access in hemodialysis patients in a hemodialysis center in Iran. J Vasc Nurs. 2012 Mar;30(1):24-8. doi: 10.1016/j.jvn.2011.10.002.
PubMed 22321404
Agharazii M, Plamondon I, Lebel M, Douville P, Desmeules S. Estimation of heparin leak into the systemic circulation after central venous catheter heparin lock. Nephrol Dial Transplant. 2005 Jun;20(6):1238-40. doi: 10.1093/ndt/gfh841. Epub 2005 Apr 26.
PubMed 15855206
Moran JE, Ash SR; ASDIN Clinical Practice Committee. Locking solutions for hemodialysis catheters; heparin and citrate--a position paper by ASDIN. Semin Dial. 2008 Sep-Oct;21(5):490-2. doi: 10.1111/j.1525-139X.2008.00466.x. Epub 2008 Aug 29.
PubMed 18764795
Chen FK, Li JJ, Song Y, Zhang YY, Chen P, Zhao CZ, Gong HY, Yao DF. Concentrated sodium chloride catheter lock solution--a new effective alternative method for hemodialysis patients with high bleeding risk. Ren Fail. 2014 Feb;36(1):17-22. doi: 10.3109/0886022X.2013.830207. Epub 2013 Sep 2.
PubMed 23992231
Palomo I, Pereira J, Alarcon M, Diaz G, Hidalgo P, Pizarro I, Jara E, Rojas P, Quiroga G, Moore-Carrasco R. Prevalence of heparin-induced antibodies in patients with chronic renal failure undergoing hemodialysis. J Clin Lab Anal. 2005;19(5):189-95. doi: 10.1002/jcla.20076.
PubMed 16170812
Yon CK, Low CL. Sodium citrate 4% versus heparin as a lock solution in hemodialysis patients with central venous catheters. Am J Health Syst Pharm. 2013 Jan 15;70(2):131-6. doi: 10.2146/ajhp120300.
PubMed 23292266
Shanks RM, Sargent JL, Martinez RM, Graber ML, O'Toole GA. Catheter lock solutions influence staphylococcal biofilm formation on abiotic surfaces. Nephrol Dial Transplant. 2006 Aug;21(8):2247-55. doi: 10.1093/ndt/gfl170. Epub 2006 Apr 20.
PubMed 16627606
Zhao Y, Li Z, Zhang L, Yang J, Yang Y, Tang Y, Fu P. Citrate versus heparin lock for hemodialysis catheters: a systematic review and meta-analysis of randomized controlled trials. Am J Kidney Dis. 2014 Mar;63(3):479-90. doi: 10.1053/j.ajkd.2013.08.016. Epub 2013 Oct 11.
PubMed 24125729
Beigi AA, HadiZadeh MS, Salimi F, Ghaheri H. Heparin compared with normal saline to maintain patency of permanent double lumen hemodialysis catheters: A randomized controlled trial. Adv Biomed Res. 2014 May 28;3:121. doi: 10.4103/2277-9175.133192. eCollection 2014.
PubMed 24949292
Zhong L, Wang HL, Xu B, Yuan Y, Wang X, Zhang YY, Ji L, Pan ZM, Hu ZS. Normal saline versus heparin for patency of central venous catheters in adult patients - a systematic review and meta-analysis. Crit Care. 2017 Jan 8;21(1):5. doi: 10.1186/s13054-016-1585-x.
PubMed 28063456
Wong DW, Mishkin FS, Tanaka TT. The effects of bicarbonate on blood coagulation. JAMA. 1980 Jul 4;244(1):61-2.
PubMed 7382058
Farha MA, French S, Stokes JM, Brown ED. Bicarbonate Alters Bacterial Susceptibility to Antibiotics by Targeting the Proton Motive Force. ACS Infect Dis. 2018 Mar 9;4(3):382-390. doi: 10.1021/acsinfecdis.7b00194. Epub 2018 Jan 4.
PubMed 29264917
Nostro A, Cellini L, Di Giulio M, D'Arrigo M, Marino A, Blanco AR, Favaloro A, Cutroneo G, Bisignano G. Effect of alkaline pH on staphylococcal biofilm formation. APMIS. 2012 Sep;120(9):733-42. doi: 10.1111/j.1600-0463.2012.02900.x. Epub 2012 Apr 11.
PubMed 22882263

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients
ClinicalTrials.gov ID: NCT04054128
Acronym / sponsor ID: BICATH / 479/01/19
Conditions: End Stage Renal Disease, Vascular Access Complication, Catheter Complications, Hemodialysis Access Failure, Hemodialysis Catheter Infection
Keywords: Sodium bicarbonate lock, Heparin lock, Vascular access complication
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (actual)
Lead sponsor: Hospital General "Dr. Miguel Silva" de MoreliaUniversity, hospital or other
Collaborators: Universidad Nacional Autonoma de Mexico, NAUSLIFE HEMODIALYSIS CLINICS
Study start: 11 Sep 2019 (actual)
Primary completion: 20 Feb 2020 (actual)
Study completion: 28 Sep 2020 (estimated)
First posted: 13 Aug 2019 (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.

Detailed description

A prospective, randomized, clinical, open-label trial at Hospital General "Dr. Miguel Silva" de Morelia, Mexico.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Prospective, open label, clinical trial in chronic hemodialysis patients with a catheter as a vascular access, randomized to bicarbonate lock or heparin lock (control) as standard treatment.

Arm	Type	Receives
Sodium bicarbonate catheter lock group (SBCL)	Experimental	Drug: Sodium Bicarbonate 7.5% InjectionChronic hemodialysis patients with a catheter as a vascular access, will be lock with sodium bicarbonate 7.5% Injection.
Heparin catheter lock group (HCL)	Active comparator	Drug: Heparin Sodium, 1000 Units/mL Injectable Solution 1Chronic hemodialysis patients with a catheter as a vascular access, will be lock with heparin, 1000 Units/mL injectable solution

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients who accept participation and sign informed consent.
Incident or prevalent chronic hemodialysis patients who receive at least 2 sessions per week with 1 month of clinical stability defined as: no hospitalizations, no vascular access infections, no changes in blood flow prescription due to vascular access dysfunction.
Patients with temporal catheter (Niagra 13.5 French/20 cm length, BARD Access System, Salt Lake City, Utah, USA) as vascular access for hemodialysis.

Key exclusion criteria (9 listed)

Catheter dysfunction at baseline
On anticoagulation therapy
Patients with known coagulopathy or hemophilia
Patients with Child-Pugh B or C liver failure
Patients with thrombocytopenia less than 100,000 u / L

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
Sodium Bicarbonate 7.5% InjectionAlso: Bicarnat® armSodium bicarbonate solution for catheter lock; 7.5% sodium bicarbonate solution will be used for catheter lock in both catheter lumens, 1.9 mL in each catheter lumen will be infused after hemodialysis treatment during 3 months.	Drug	Sodium bicarbonate catheter lock group (SBCL)
Heparin Sodium, 1000 Units/mL Injectable Solution 1Also: Inhepar® armHeparin for catheter lock: 1000 u/mL heparin solution will be used for catheter lock in both catheter lumens as standard treatment, 1.9 mL in each catheter lumen will be infused after hemodialysis treatment during 3 months.	Drug	Heparin catheter lock group (HCL)

Primary outcome

Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients
Time frame: 30 days.
Arterial line pressure[mmHg] at 300 mL/min blood flow will be compared between sodium bicarbonate lock and heparin lock in chronic hemodialysis patients.
Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients
Time frame: 60 days
Arterial line pressure[mmHg] at 300 mL/min blood flow will be compared between sodium bicarbonate lock and heparin lock in chronic hemodialysis patients.
Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients
Time frame: 90 days
Arterial line pressure[mmHg] at 300 mL/min blood flow will be compared between sodium bicarbonate lock and heparin lock in chronic hemodialysis patients.

3 secondary outcomes

Incidence rate of catheter related bloodstream infection
Time frame: 90 days
Incidence rate of catheter thrombosis
Time frame: 90 days
Adverse events incidence
Time frame: 90 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
Background: PubMed 23727169Jha V, Garcia-Garcia G, Iseki K, Li Z, Naicker S, Plattner B, Saran R, Wang AY, Yang CW. Chronic kidney disease: global dimension and perspectives. Lancet. 2013 Jul 20;382(9888):260-72. doi: 10.1016/S0140-6736(13)60687-X. Epub 2013 May 31.
Background: PubMed 23052655Ma A, Shroff R, Hothi D, Lopez MM, Veligratli F, Calder F, Rees L. A comparison of arteriovenous fistulas and central venous lines for long-term chronic haemodialysis. Pediatr Nephrol. 2013 Feb;28(2):321-6. doi: 10.1007/s00467-012-2318-2. Epub 2012 Oct 6.
Background: PubMed 22321404Adib-Hajbaghery M, Molavizadeh N, Alavi NM. Quality of care of vascular access in hemodialysis patients in a hemodialysis center in Iran. J Vasc Nurs. 2012 Mar;30(1):24-8. doi: 10.1016/j.jvn.2011.10.002.
Background: PubMed 15855206Agharazii M, Plamondon I, Lebel M, Douville P, Desmeules S. Estimation of heparin leak into the systemic circulation after central venous catheter heparin lock. Nephrol Dial Transplant. 2005 Jun;20(6):1238-40. doi: 10.1093/ndt/gfh841. Epub 2005 Apr 26.
Background: PubMed 18764795Moran JE, Ash SR; ASDIN Clinical Practice Committee. Locking solutions for hemodialysis catheters; heparin and citrate--a position paper by ASDIN. Semin Dial. 2008 Sep-Oct;21(5):490-2. doi: 10.1111/j.1525-139X.2008.00466.x. Epub 2008 Aug 29.
Background: PubMed 23992231Chen FK, Li JJ, Song Y, Zhang YY, Chen P, Zhao CZ, Gong HY, Yao DF. Concentrated sodium chloride catheter lock solution--a new effective alternative method for hemodialysis patients with high bleeding risk. Ren Fail. 2014 Feb;36(1):17-22. doi: 10.3109/0886022X.2013.830207. Epub 2013 Sep 2.
Background: PubMed 16170812Palomo I, Pereira J, Alarcon M, Diaz G, Hidalgo P, Pizarro I, Jara E, Rojas P, Quiroga G, Moore-Carrasco R. Prevalence of heparin-induced antibodies in patients with chronic renal failure undergoing hemodialysis. J Clin Lab Anal. 2005;19(5):189-95. doi: 10.1002/jcla.20076.
Background: PubMed 23292266Yon CK, Low CL. Sodium citrate 4% versus heparin as a lock solution in hemodialysis patients with central venous catheters. Am J Health Syst Pharm. 2013 Jan 15;70(2):131-6. doi: 10.2146/ajhp120300.
Background: PubMed 16627606Shanks RM, Sargent JL, Martinez RM, Graber ML, O'Toole GA. Catheter lock solutions influence staphylococcal biofilm formation on abiotic surfaces. Nephrol Dial Transplant. 2006 Aug;21(8):2247-55. doi: 10.1093/ndt/gfl170. Epub 2006 Apr 20.
Background: PubMed 24125729Zhao Y, Li Z, Zhang L, Yang J, Yang Y, Tang Y, Fu P. Citrate versus heparin lock for hemodialysis catheters: a systematic review and meta-analysis of randomized controlled trials. Am J Kidney Dis. 2014 Mar;63(3):479-90. doi: 10.1053/j.ajkd.2013.08.016. Epub 2013 Oct 11.
Background: PubMed 24949292Beigi AA, HadiZadeh MS, Salimi F, Ghaheri H. Heparin compared with normal saline to maintain patency of permanent double lumen hemodialysis catheters: A randomized controlled trial. Adv Biomed Res. 2014 May 28;3:121. doi: 10.4103/2277-9175.133192. eCollection 2014.
Background: PubMed 28063456Zhong L, Wang HL, Xu B, Yuan Y, Wang X, Zhang YY, Ji L, Pan ZM, Hu ZS. Normal saline versus heparin for patency of central venous catheters in adult patients - a systematic review and meta-analysis. Crit Care. 2017 Jan 8;21(1):5. doi: 10.1186/s13054-016-1585-x.
Individual participant dataSharing planned: No

Related trials for End Stage Renal Disease

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Recruiting
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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.

Israel Campos, M.D. principal investigator

Hospital General "Dr. Miguel Silva" de Morelia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 9 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 30 Apr 2020. 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 Mexico. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients (time frame: 30 days.). The study lists 3 primary outcomes in all. 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 NCT04054128, which also lists 15 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 30 Apr 2020.