Oxidative Stress and Circulating Nuclear DNA (cfDNA) in Acute Kidney Injury and Continuous Renal Replacement Therapies.

Summary

Acute kidney injury (AKI) is the inability of the kidneys to perform their functions of purifying and cleaning the blood. It is a frequent complication in hospitalized patients, especially in those admitted to the ICUs. In these situations is common to use machines to artificially and temporarily replace renal function so waste products that can be toxic are removed from the body.

The purpose of this study is to assess the effectiveness and safety of two anticoagulation strategies of the extracorporeal purification system in critically ill patients with acute kidney injury treated with continuous renal replacement therapy (CRRT) evaluating the effect of both strategies in oxidative stress and extracellular nucleosomes and its influence on the recovery of renal function.

Conditions

• Acute Kidney Injury

Interventions

PROCEDURE

Central venous access

Venous access will be achieved with a 13 Fr double lumen catheter into the internal jugular or femoral vein.

DEVICE

Pump-assisted circuit

The pump-assisted circuit to be used will be Fresenius multiFiltrate (Fresenius Medical Care GmbH, Bad Homburg v.d.H., Germany). EMIC2® Fresenius Medical Care high-flux synthetic membrane will be used

DRUG

Heparin sodium

Non-fractional heparin will be used in one arm with an initial dose of 500-1000 IU/hour with adaptation of the infusion to the patient and the clotting time.

OTHER

Regional citrate anticoagulation

Regional citrate anticoagulation will be used in the other arm with an initial dose of 3 mmol/L and with a calcium reinfusion solution at an initial dose of 2 mmol/L, with adaptation of both infusions to the patient ionic calcium levels.

PROCEDURE

Blood and ultrafiltrate samples

Blood samples will be taken from the prefilter (inlet filter plasma concentration \[Ci\]) and postfilter (outlet filter plasma concentration \[Co\]) sites of the extracorporeal circulation circuit. The ultrafiltrate will be collected directly from the outlet of the hemofilter (ultrafiltrate concentration \[Cuf\]). The samples will taken at the beginning of CRRT (T0) and at the following times: T0, Ci; after 60 min (T1) and after 24 hours (T2) of CRRT, Ci, Co and Cuf. Venous access will be achieved with a 13 Fr double lumen catheter into the internal jugular or femoral vein.

Sponsors & Collaborators

• Hospital Universitario de la Plana

  collaborator OTHER

• Hospital General Universitario de Castellón

  collaborator OTHER

• Fernando Sanchez

  lead OTHER

Principal Investigators

• Fernando Sanchez, MD · La Plana Health Department. Valencian Health Counseling

• Fernando Sanchez, MD · La Plana Health Department. Valencian Health Counseling

• Fernando Sanchez, MD · La Plana Health Department. Valencian Health Counseling

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-09

Primary Completion

2021-04-30

Completion

2021-04-30

Countries

• Spain

Study Locations