HemodiafiltrationNCT04033029

Antibiotic Plasma Concentrations During Continuous Renal Replacement Therapy With a High Adsorption Membrane (oXiris®)

An observational study of Hemodiafiltration and Sepsis, run by Hospital Universitari de Bellvitge at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Study: Open label, non-randomized, observational, descriptive and prospective pharmacokinetic. Patients: sepsis patients undergoing continuous renal replacement therapy (CRRT) and admitted at the Intensive care unit of Bellvitge University Hospitals. No power calculations needed. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hemodiafiltration, Sepsis, Acute Kidney Injury
What is being tested?: Continuous venovenous hemodiafiltration with high adsorption membrane (oXiris®) and Antibiotics
Type of treatment: Medical device
How many people: 20 participants
Where: 1 siteSpain
Study dates: 1 Jan 2021to 30 Jun 2023
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Critically ill patients under continuous venovenous hemodiafiltration (CVVHDF) by using the PrismafleX eXeed™ system with a high adsorbent membrane (oXiris®) and requiring antibiotic treatment with: piperacillin, ceftazidime, cefepime, ceftolozane/tazobactam or daptomycin.

Who may be able to join

Patients in the setting of sepsis and requirements of CRRT with high adsorption membranes for at least 48 h
Age >18 years
Treatment with piperacillin, ceftazidime, cefepime, ceftolozane and daptomycin prescribed at the discretion of the treating intensive care physician.
Written informed consent will be required before the inclusion of a patient whenever possible and will be requested from the nearest relatives in the other cases.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Helena Colom Codina
Barcelona

Other trials in Spain

About this study

Study: Open label, non-randomized, observational, descriptive and prospective pharmacokinetic.
Patients: sepsis patients undergoing continuous renal replacement therapy (CRRT) and admitted at the Intensive care unit of Bellvitge University Hospitals. No power calculations needed.
Antibiotic treatment: piperacillin, ceftazidime, cefepime, ceftolozane and daptomycin as their standard of care and doses will be at the discretion of the treating physician.
CRRT treatment: continuous venovenous hemodiafiltration (CVVHDF) will be performed by using the PrismafleX eXeed™ system with a high adsorbent membrane (oXiris®).
Antibiotic concentrations: blood pre and post filter, urine and ultrafiltrate samples will be collected at steady state conditions. Samplig time will depend on dosage regimens of each antibiotic.

Read the detailed description

The study is an open label, non-randomized, observational, descriptive and prospective pharmacokinetic study.

Setting: this study will be conducted at the Intensive Care Unit at the Bellvitge University Hospital.

Study aims: the primary objective is to determine the PK/PD target attainment of piperacillin, ceftazidime, cefepime, ceftolozane and daptomycin in septic critically ill patients treated with CVVHDF using oXiris® membrane. Secondary aims are: i) to characterize the PK of piperacillin, ceftazidime, cefepime, ceftolozane and daptomycin in critically ill patients under CVVHDF therapy using oXiris® membrane by developing a population PK model; ii) to identify the clinical and demographic sources of PK variability observed in these patient and iii) to develop individualized dosing recommendations based on the PK/PD index associated with therapy success.

Recruitment process: patients who meet the inclusion criteria will be enrolled for at least 72 hours (maximum 96 hours).

Sample size: no power calculations are required for this study as it aims to investigate the PK of these antibiotics and does not intend to measure the effect of an intervention between two groups.

Antibiotic treatment: patients will receive piperacillin, ceftazidime, cefepime, ceftolozane/tazobactam or daptomycin as their standard of care. Doses will be at the discretion of the treating physician. At the same time, patients will be treated under continuous renal replacement techniques (CRRT) with continuous venovenous hemodiafiltration mode (CVVHDF) using PrismafleX eXeed™ system and high adsorbent polyethyleneimide membrane (oXiris®). Filtration parameters will be determined following the local protocol (dose of 25-30 ml/kg/h) CRRT initiation will be determined by the treating physician on charge, according with the current recommendations of clinical practice and prescriptions of CRRT and local management protocols. The decision to stop the treatment will be determined by:

Adequate renal recovery status: adequate capacity to effectively maintain fluid and electrolyte homeostasis and urinary output (>450 ml in 24 h) without the use of diuretics.
Hemodynamic stability without renal function recovery. Therapy will be continued as intermittent hemodialysis.

Antibiotic concentrations: blood, either pre and post filtration through oXiris® membrane, urine and ultrafiltrate samples will be obtained. Samples will be collected at 1) steady state conditions and 2) after minimum 24h from the concomitant administration of CRRT and antibiotic for piperacillin, ceftazidime, cefepime, ceftolozane and 48h for daptomycin. Sampling times will depend on the dosage regimen of each antibiotic therapy. Drug concentrations will be determined using a previously developed and validated measurement procedure based on ultra-high performance liquid chromatography-tandem mass spectrometry.

Conditions: Hemodiafiltration, Sepsis, Acute Kidney Injury
Being tested: Continuous venovenous hemodiafiltration with high adsorption membrane (oXiris®), Antibiotics
Keywords: Acute kidney Injury, Sepsis, Antibiotic plasma level, CRRT, oXiris®
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.

Continuous venovenous hemodiafiltration with high adsorption membrane (oXiris®)Device
CRRT initiation will be determined by the treating physician on charge, according with the current recommendations of clinical practice and prescriptions of CRRT and local management protocols. The CVVHDF mode will be performed by using PrismafleX eXeed™ system and high adsorbent polyethyleneimide membrane (oXiris®). Filtration parameters will be determined following the local protocol (dose of 25-30 ml/kg/h).
AntibioticsDrug
Also called Piperacillin/tazobactam, Ceftazidime, Cefepime, Daptomycin
Antibiotic concentration-time data will be collected and analyzed.

Study groups in NCT04033029
Study group	Role	What they receive
Patients under CVVHDF with high adsorption membrane		Continuous venovenous hemodiafiltration mode (CVVHDF) using PrismafleX eXeed™ system and high adsorbent polyethyleneimide membrane (oXiris®). Filtration parameters will be determined following the local protocol (dose of 25-30 ml/kg/h). Receives: Device: Continuous venovenous hemodiafiltration with high adsorption membrane (oXiris®); Drug: Antibiotics

What is being measured

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

Number of individuals attaining a defined pharmacokinetic-pharmacodynamic target for antimicrobial therapy
Time above minimum inhibitory concentration (%fT > k× MIC) for betalactams, and total-drug AUC24/MIC ≥ 666 for daptomycin
Measured: 01/08/2019 - 31/12/2021

Secondary outcomes (11)

Antibiotic concentration-time data.
Antibiotic concentration-time data will be collected and analysed to characterize the PK profile of piperacillin, ceftazidime, cefepime, ceftolozane and daptomycin in critically ill patients under CRRT therapy using oXiris® membrane and a population PK model will be developed.
Measured: 01/08/2019 - 31/12/2021
Blood flow (mL/min). CRRT covariate that can affect drug exposure and PK parameters.
Effect of CRRT settings, physiopathological and demographic data on drug exposure and PK parameters.
Measured: 01/08/2019 - 31/12/2021
Dialysate flow rate (L/h).
CRRT covariate that can affect drug exposure and PK parameters. For each antibiotic, a population pharmacokinetic model will be developed.
Measured: 01/08/2019 - 31/12/2021
Ultrafiltrate flow rate (L/h).
CRRT covariate that can affect drug exposure and PK parameters. For each antibiotic, a population pharmacokinetic model will be developed.
Measured: 01/08/2019 - 31/12/2021
Replacement fluid (mL/h).
CRRT covariate that can affect drug exposure and PK parameters. For each antibiotic, a population pharmacokinetic model will be developed.
Measured: 01/08/2019 - 31/12/2021
Extraction rate (L/h).
CRRT covariate that can affect drug exposure and PK parameters. For each antibiotic, a population pharmacokinetic model will be developed.
Measured: 01/08/2019 - 31/12/2021
Urine output (mL/day).
Physiopathological variables that can affect drug exposure and PK parameters. For each antibiotic, a population pharmacokinetic model will be developed.
Measured: 01/08/2019 - 31/12/2021
Albumin (g/L).
Physiopathological variables that can affect drug exposure and PK parameters. For each antibiotic, a population pharmacokinetic model will be developed.
Measured: 01/08/2019 - 31/12/2021
Weight (Kg).
Physiopathological variables that can affect drug exposure and PK parameters. For each antibiotic, a population pharmacokinetic model will be developed.
Measured: 01/08/2019 - 31/12/2021
Admission diagnosis: surgical, medical, trauma.
Physiopathological variables that can affect drug exposure and PK parameters. For each antibiotic, a population pharmacokinetic model will be developed.
Measured: 01/08/2019 - 31/12/2021
Dosage (mg, frequency of administration and mode of administration) needed to achieve the PK/PD target.
Monte-Carlo Simulations using the population PK parameters of the final models in order to generate concentration-time profiles of n hypothetical subjects per dosing regimen will be performed. With this data, we will calculate the probability of target attainment of the PK/PD indices associated to antibiotic therapy success, which will translate in the development of individualized dosing recommendations for our patient population.
Measured: 01/08/2019 - 31/12/2021

Timeline

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

1 Jan 202130 Jun 2023

First posted25 Jul 2019
Study start1 Jan 2021
Primary completion30 Jun 2023
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for HemodiafiltrationStudies 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: Other
Time perspective: Prospective
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04033029
Sponsor's protocol ID: HCC-PIP-2018-01
Status last verified: Oct 2023
First submitted: 20 Feb 2019
Last updated: 10 Oct 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.
PubMed 19952319
Brun-Buisson C. The epidemiology of the systemic inflammatory response. Intensive Care Med. 2000;26 Suppl 1(Suppl 1):S64-74. doi: 10.1007/s001340051121.
PubMed 10786961
Kollef MH, Sherman G, Ward S, Fraser VJ. Inadequate antimicrobial treatment of infections: a risk factor for hospital mortality among critically ill patients. Chest. 1999 Feb;115(2):462-74. doi: 10.1378/chest.115.2.462.
PubMed 10027448
Zaragoza R, Artero A, Camarena JJ, Sancho S, Gonzalez R, Nogueira JM. The influence of inadequate empirical antimicrobial treatment on patients with bloodstream infections in an intensive care unit. Clin Microbiol Infect. 2003 May;9(5):412-8. doi: 10.1046/j.1469-0691.2003.00656.x.
PubMed 12848754
Pinder M, Bellomo R, Lipman J. Pharmacological principles of antibiotic prescription in the critically ill. Anaesth Intensive Care. 2002 Apr;30(2):134-44. doi: 10.1177/0310057X0203000203.
PubMed 12002919
Ibrahim EH, Sherman G, Ward S, Fraser VJ, Kollef MH. The influence of inadequate antimicrobial treatment of bloodstream infections on patient outcomes in the ICU setting. Chest. 2000 Jul;118(1):146-55. doi: 10.1378/chest.118.1.146.
PubMed 10893372
Craig WA. Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis. 1998 Jan;26(1):1-10; quiz 11-2. doi: 10.1086/516284.
PubMed 9455502
Roberts JA, Roberts MS, Robertson TA, Dalley AJ, Lipman J. Piperacillin penetration into tissue of critically ill patients with sepsis--bolus versus continuous administration? Crit Care Med. 2009 Mar;37(3):926-33. doi: 10.1097/CCM.0b013e3181968e44.
PubMed 19237898
Heinemeyer G, Link J, Weber W, Meschede V, Roots I. Clearance of ceftriaxone in critical care patients with acute renal failure. Intensive Care Med. 1990;16(7):448-53. doi: 10.1007/BF01711224.
PubMed 2269714
Trotman RL, Williamson JC, Shoemaker DM, Salzer WL. Antibiotic dosing in critically ill adult patients receiving continuous renal replacement therapy. Clin Infect Dis. 2005 Oct 15;41(8):1159-66. doi: 10.1086/444500. Epub 2005 Sep 12.
PubMed 16163635
Carcelero San Martin E, Soy Muner D. [Dosage of antipseudomonal antibiotics in patients with acute kidney injury subjected to continuous renal replacement therapies]. Med Intensiva. 2013 Apr;37(3):185-200. doi: 10.1016/j.medin.2012.02.012. Epub 2012 Apr 3. Spanish.
PubMed 22475763
Matzke GR, Frye RF, Joy MS, Palevsky PM. Determinants of ceftazidime clearance by continuous venovenous hemofiltration and continuous venovenous hemodialysis. Antimicrob Agents Chemother. 2000 Jun;44(6):1639-44. doi: 10.1128/AAC.44.6.1639-1644.2000.
PubMed 10817721
Bauer SR, Salem C, Connor MJ Jr, Groszek J, Taylor ME, Wei P, Tolwani AJ, Fissell WH. Pharmacokinetics and pharmacodynamics of piperacillin-tazobactam in 42 patients treated with concomitant CRRT. Clin J Am Soc Nephrol. 2012 Mar;7(3):452-7. doi: 10.2215/CJN.10741011. Epub 2012 Jan 26.
PubMed 22282479
Valtonen M, Tiula E, Backman JT, Neuvonen PJ. Elimination of meropenem during continuous veno-venous haemofiltration and haemodiafiltration in patients with acute renal failure. J Antimicrob Chemother. 2000 May;45(5):701-4. doi: 10.1093/jac/45.5.701.
PubMed 10797097
Roberts DM, Roberts JA, Roberts MS, Liu X, Nair P, Cole L, Lipman J, Bellomo R; RENAL Replacement Therapy Study Investigators. Variability of antibiotic concentrations in critically ill patients receiving continuous renal replacement therapy: a multicentre pharmacokinetic study. Crit Care Med. 2012 May;40(5):1523-8. doi: 10.1097/CCM.0b013e318241e553.
PubMed 22511133

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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Recruiting
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All Hemodiafiltration trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Antibiotic Plasma Concentrations During Continuous Renal Replacement Therapy With a High Adsorption Membrane (oXiris®)
ClinicalTrials.gov ID: NCT04033029
Acronym / sponsor ID: HCC-PIP-2018-01
Conditions: Hemodiafiltration, Sepsis, Acute Kidney Injury
Keywords: Acute kidney Injury, Sepsis, Antibiotic plasma level, CRRT, oXiris®
Study type: Observational
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Hospital Universitari de BellvitgeUniversity, hospital or other
Collaborators: Baxter Healthcare Corporation
Study start: 1 Jan 2021 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 25 Jul 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.

Study: Open label, non-randomized, observational, descriptive and prospective pharmacokinetic.
Patients: sepsis patients undergoing continuous renal replacement therapy (CRRT) and admitted at the Intensive care unit of Bellvitge University Hospitals. No power calculations needed.
Antibiotic treatment: piperacillin, ceftazidime, cefepime, ceftolozane and daptomycin as their standard of care and doses will be at the discretion of the treating physician.
CRRT treatment: continuous venovenous hemodiafiltration (CVVHDF) will be performed by using the PrismafleX eXeed™ system with a high adsorbent membrane (oXiris®).
Antibiotic concentrations: blood pre and post filter, urine and ultrafiltrate samples will be collected at steady state conditions. Samplig time will depend on dosage regimens of each antibiotic.

Detailed description

The study is an open label, non-randomized, observational, descriptive and prospective pharmacokinetic study.

Setting: this study will be conducted at the Intensive Care Unit at the Bellvitge University Hospital.

Recruitment process: patients who meet the inclusion criteria will be enrolled for at least 72 hours (maximum 96 hours).

Sample size: no power calculations are required for this study as it aims to investigate the PK of these antibiotics and does not intend to measure the effect of an intervention between two groups.

Adequate renal recovery status: adequate capacity to effectively maintain fluid and electrolyte homeostasis and urinary output (>450 ml in 24 h) without the use of diuretics.
Hemodynamic stability without renal function recovery. Therapy will be continued as intermittent hemodialysis.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients under CVVHDF with high adsorption membrane	–	Device: Continuous venovenous hemodiafiltration with high adsorption membrane (oXiris®), Drug: AntibioticsContinuous venovenous hemodiafiltration mode (CVVHDF) using PrismafleX eXeed™ system and high adsorbent polyethyleneimide membrane (oXiris®). Filtration parameters will be determined following the local protocol (dose of 25-30 ml/kg/h).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Critically ill patients under continuous venovenous hemodiafiltration (CVVHDF) by using the PrismafleX eXeed™ system with a high adsorbent membrane (oXiris®) and requiring antibiotic treatment with: piperacillin, ceftazidime, cefepime, ceftolozane/tazobactam or daptomycin.

Key inclusion criteria (4 listed)

Patients in the setting of sepsis and requirements of CRRT with high adsorption membranes for at least 48 h
Age >18 years
Treatment with piperacillin, ceftazidime, cefepime, ceftolozane and daptomycin prescribed at the discretion of the treating intensive care physician.
Written informed consent will be required before the inclusion of a patient whenever possible and will be requested from the nearest relatives in the other cases.

Key exclusion criteria (0 listed)

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
Continuous venovenous hemodiafiltration with high adsorption membrane (oXiris®)CRRT initiation will be determined by the treating physician on charge, according with the current recommendations of clinical practice and prescriptions of CRRT and local management protocols. The CVVHDF mode will be performed by using PrismafleX eXeed™ system and high adsorbent polyethyleneimide membrane (oXiris®). Filtration parameters will be determined following the local protocol (dose of 25-30 ml/kg/h).	Device	Patients under CVVHDF with high adsorption membrane
AntibioticsAlso: Piperacillin/tazobactam, Ceftazidime, Cefepime, DaptomycinAntibiotic concentration-time data will be collected and analyzed.	Drug	Patients under CVVHDF with high adsorption membrane

Primary outcome

Number of individuals attaining a defined pharmacokinetic-pharmacodynamic target for antimicrobial therapy
Time frame: 01/08/2019 - 31/12/2021
Time above minimum inhibitory concentration (%fT > k× MIC) for betalactams, and total-drug AUC24/MIC ≥ 666 for daptomycin

11 secondary outcomes

Antibiotic concentration-time data.
Time frame: 01/08/2019 - 31/12/2021
Blood flow (mL/min). CRRT covariate that can affect drug exposure and PK parameters.
Time frame: 01/08/2019 - 31/12/2021
Dialysate flow rate (L/h).
Time frame: 01/08/2019 - 31/12/2021
Ultrafiltrate flow rate (L/h).
Time frame: 01/08/2019 - 31/12/2021
Replacement fluid (mL/h).
Time frame: 01/08/2019 - 31/12/2021
Extraction rate (L/h).
Time frame: 01/08/2019 - 31/12/2021
Urine output (mL/day).
Time frame: 01/08/2019 - 31/12/2021
Albumin (g/L).
Time frame: 01/08/2019 - 31/12/2021
Weight (Kg).
Time frame: 01/08/2019 - 31/12/2021
Admission diagnosis: surgical, medical, trauma.
Time frame: 01/08/2019 - 31/12/2021
Dosage (mg, frequency of administration and mode of administration) needed to achieve the PK/PD target.
Time frame: 01/08/2019 - 31/12/2021

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 10 Oct 2023.
Background: PubMed 19952319Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.
Background: PubMed 10786961Brun-Buisson C. The epidemiology of the systemic inflammatory response. Intensive Care Med. 2000;26 Suppl 1(Suppl 1):S64-74. doi: 10.1007/s001340051121.
Background: PubMed 10027448Kollef MH, Sherman G, Ward S, Fraser VJ. Inadequate antimicrobial treatment of infections: a risk factor for hospital mortality among critically ill patients. Chest. 1999 Feb;115(2):462-74. doi: 10.1378/chest.115.2.462.
Background: PubMed 12848754Zaragoza R, Artero A, Camarena JJ, Sancho S, Gonzalez R, Nogueira JM. The influence of inadequate empirical antimicrobial treatment on patients with bloodstream infections in an intensive care unit. Clin Microbiol Infect. 2003 May;9(5):412-8. doi: 10.1046/j.1469-0691.2003.00656.x.
Background: PubMed 12002919Pinder M, Bellomo R, Lipman J. Pharmacological principles of antibiotic prescription in the critically ill. Anaesth Intensive Care. 2002 Apr;30(2):134-44. doi: 10.1177/0310057X0203000203.
Background: PubMed 10893372Ibrahim EH, Sherman G, Ward S, Fraser VJ, Kollef MH. The influence of inadequate antimicrobial treatment of bloodstream infections on patient outcomes in the ICU setting. Chest. 2000 Jul;118(1):146-55. doi: 10.1378/chest.118.1.146.
Background: PubMed 9455502Craig WA. Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis. 1998 Jan;26(1):1-10; quiz 11-2. doi: 10.1086/516284.
Background: PubMed 19237898Roberts JA, Roberts MS, Robertson TA, Dalley AJ, Lipman J. Piperacillin penetration into tissue of critically ill patients with sepsis--bolus versus continuous administration? Crit Care Med. 2009 Mar;37(3):926-33. doi: 10.1097/CCM.0b013e3181968e44.
Background: PubMed 2269714Heinemeyer G, Link J, Weber W, Meschede V, Roots I. Clearance of ceftriaxone in critical care patients with acute renal failure. Intensive Care Med. 1990;16(7):448-53. doi: 10.1007/BF01711224.
Background: PubMed 16163635Trotman RL, Williamson JC, Shoemaker DM, Salzer WL. Antibiotic dosing in critically ill adult patients receiving continuous renal replacement therapy. Clin Infect Dis. 2005 Oct 15;41(8):1159-66. doi: 10.1086/444500. Epub 2005 Sep 12.
Background: PubMed 22475763Carcelero San Martin E, Soy Muner D. [Dosage of antipseudomonal antibiotics in patients with acute kidney injury subjected to continuous renal replacement therapies]. Med Intensiva. 2013 Apr;37(3):185-200. doi: 10.1016/j.medin.2012.02.012. Epub 2012 Apr 3. Spanish.
Background: PubMed 10817721Matzke GR, Frye RF, Joy MS, Palevsky PM. Determinants of ceftazidime clearance by continuous venovenous hemofiltration and continuous venovenous hemodialysis. Antimicrob Agents Chemother. 2000 Jun;44(6):1639-44. doi: 10.1128/AAC.44.6.1639-1644.2000.
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.

Helena Colom Codina, Phd principal investigator

Universitat Autònoma de Barcelona

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 Hemodiafiltration and Sepsis, run by Hospital Universitari de Bellvitge at 1 site in Spain.

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 0 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 10 Oct 2023. 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 Spain. 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?

Number of individuals attaining a defined pharmacokinetic-pharmacodynamic target for antimicrobial therapy (time frame: 01/08/2019 - 31/12/2021). 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 NCT04033029, which also lists 17 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 10 Oct 2023; AzTrials last refreshed its copy on 30 Oct 2026.