A study to assess the effect in renal function recovery of two anticoagulation strategies (ways of making blood more fluent) in critically ill patients with acute kidney failure treated with continuous renal replacement therapies.

Oxidative stress and extracellular nucleosomes in critically ill patients with acute kidney failure treated with continuous renal replacement therapies. Effect of two anticoagulation strategies of the extracorporeal purification system in renal function recovery.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004361-12-ES

Enrollment

Unknown

Registered

2017-02-10

Start date

2017-03-27

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute renal failure (ARF). MedDRA version: 19.1 Level: PT Classification code 10074746 Term: Renal replacement therapy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 19.1 Level: LLT Classification code 10038436 Term: Renal failure acute System Organ Class: 100000004857

Interventions

Trade Name: Heparin sodium Pharmaceutical Form: Anticoagulant and preservative solution for blood INN or Proposed INN: HEPARIN SODIUM Other descriptive name: HEPARIN SODIUM Concentration unit: IU/kg i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Adult intensive care patients (age = 18 years) admitted to the ICU with ARF requiring treatment with continuous renal replacement technique. • Patients able to accept being included in the study by signing the Informed Consent (IC). If the patient can not give consent, family consent is requested and, by default, the opinion of the person of trust or designated decision, if present. If there is no family present, trusted person or legal representative designated, the possibility of deferred consent is not contemplated. In this case the patient will not be included in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22

Exclusion criteria

Exclusion criteria: • Age under 18 or over 80 years. • Pregnancy and/or lactation. • Terminal diseases or life expectancy lower than 48 hours. • Increased risk of bleeding (defined as platelet count less than 40x109 / L, partial thromboplastin time -TTPA- over 60 seconds, prothrombin time international normalized ratio -PT-INR- greater than 2.0 or recent major bleeding). • Need of systemic anticoagulation therapy. • Contraindication for heparin. • Heparin-induced Thrombocytopenia (HIT). • Dialysis in the 24 hours prior to inclusion. • hypercalcemia (> 3 mmol / L). • Severe Hepatitis (GOT or GPT> 1000 IU / L). • Cirrhosis. • Inclusion in another research protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To compare the effect on bio-incompatibility induced oxidative stress and systemic oxidative stress in critically ill patients with ARF using two anticoagulation strategies of the extracorporeal system in continuous renal replacement therapies (CRRT) (heparin vs citrate). 2. To compare the effect on extracellular levels of circulating nucleosomes in critically ill patients with ARF employing two anticoagulation strategies of the extracorporeal system CRRT (heparin vs citrate). 3. To evaluate the clinical impact in terms of recovery of renal function in critically ill patients with ARF when two anticoagulation strategies of the extracorporeal system CRRT (heparin vs citrate) are used.;Secondary Objective: 1. To evaluate the differences in activation and in elimination of biomarkers of inflammation and infection with two anticoagulation strategies of the extracorporeal system CRRT (heparin vs citrate). 2. To measure the mass transfer, clearance and impact on the plasma concentration of free radicals, antioxidants and circulating nucleosomes during the course of therapy and compare the differences between the two anticoagulation strategies of the extracorporeal system CRRT (heparin vs citrate). 3. To compare the final result, in terms of stay and survival in critically ill patients with ARF when two anticoagulation strategies of the extracorporeal system CRRT (heparin vs citrate) are used.;Primary end point(s): • Lenght of renal replacement therapy (RRT). • Renal function at discharge from the ICU and hospital.;Timepoint(s) of evaluation of this end point: • Definitive discontinuation of RRT. • ICU and hospital discharge.	—

Measure

Time frame

Main Objective: 1. To compare the effect on bio-incompatibility induced oxidative stress and systemic oxidative stress in critically ill patients with ARF using two anticoagulation strategies of the extracorporeal system in continuous renal replacement therapies (CRRT) (heparin vs citrate). 2. To compare the effect on extracellular levels of circulating nucleosomes in critically ill patients with ARF employing two anticoagulation strategies of the extracorporeal system CRRT (heparin vs citrate). 3. To evaluate the clinical impact in terms of recovery of renal function in critically ill patients with ARF when two anticoagulation strategies of the extracorporeal system CRRT (heparin vs citrate) are used.;Secondary Objective: 1. To evaluate the differences in activation and in elimination of biomarkers of inflammation and infection with two anticoagulation strategies of the extracorporeal system CRRT (heparin vs citrate). 2. To measure the mass transfer, clearance and impact on the plasma concentration of free radicals, antioxidants and circulating nucleosomes during the course of therapy and compare the differences between the two anticoagulation strategies of the extracorporeal system CRRT (heparin vs citrate). 3. To compare the final result, in terms of stay and survival in critically ill patients with ARF when two anticoagulation strategies of the extracorporeal system CRRT (heparin vs citrate) are used.;Primary end point(s): • Lenght of renal replacement therapy (RRT). • Renal function at discharge from the ICU and hospital.;Timepoint(s) of evaluation of this end point: • Definitive discontinuation of RRT. • ICU and hospital discharge.

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Secondary

Measure	Time frame
Secondary end point(s): • Plasma clearance of free radicals and inflammation biomarkers. • Changes in plasma concentration of free radicals and inflammation biomarkers. • Sieving coefficient of free radicals and inflammation biomarkers. • Lenght of stay in ICU. • Lenght of stay in hospital. • ICU mortality. • Hospital mortality.;Timepoint(s) of evaluation of this end point: • 24 hours after de initiation of the therapy. • Definitive discontinuation of RRT. • ICU and hospital discharge.	—

Measure

Time frame

Secondary end point(s): • Plasma clearance of free radicals and inflammation biomarkers. • Changes in plasma concentration of free radicals and inflammation biomarkers. • Sieving coefficient of free radicals and inflammation biomarkers. • Lenght of stay in ICU. • Lenght of stay in hospital. • ICU mortality. • Hospital mortality.;Timepoint(s) of evaluation of this end point: • 24 hours after de initiation of the therapy. • Definitive discontinuation of RRT. • ICU and hospital discharge.

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Countries

Spain

Contacts

Public ContactFernando Sánchez

Fernando Sánchez

sanchez_fermor@gva.es34625978412

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026