STUDY OF SAFETY AND VIABILITY TO EVALUATE THE POTENTIAL NEUROPROTECTIVE EFFECT OF PERITONEAL DYALISIS IN THE STROKE

OPEN, RANDOMIZED AND CONTROLLED STUDY OF SAFETY AND VIABILITY, TO EVALUATE THE NEUROPROTECTIVE EFFECT OF PLASMA GLUTAMATE DIALYSIS IN ACUTE ISCHEMIC STROKE. - SAFETY OF PERITONEAL DYALISIS IN STROKE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000791-42-ES

Enrollment

Unknown

Registered

2012-05-29

Start date

2012-07-26

Completion date

Unknown

Last updated

2016-05-17

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

Conditions

BRAIN ISCHEMIC STROKE IN ACUTE PHASE

Interventions

Trade Name: PHYSIONEAL 35 GLUCOSE 1,36% P/V (DYALISIS PERITONEAL SOLUTION). Product Name: Physioneal 35 Solution for Peritoneal Dialysis Product Code: B05DB00 Pharmaceutical Form: Solution for periton

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients 18 to 80 years-old with acute ischemic stroke in the territory of the middle cerebral artery, which can not be applied pharmacological thrombolysis or mechanical thrombectomy, with less than 12h duration and have given consent. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: -Patients with previous functional dependency (mRS>2), -presence of minor neurological deficit (NIHSS scale 20), -state of coma, - posterior territory stroke; - lacunar stroke with symptoms (pure hemiparesis, pure hemihypoestesia, dysarthria, clumsy hand, ataxia, hemiparesis), -haematological diseases, infectious, inflammatory or neoplastic known at the time of treatment, -pregnancy or lactation (urine analysis be performed prior to randomization in women of childbearing age), -renal impairment (CLcr 1.5 mg/dl) previously known; - severe liver disease, any comorbility status at the discretion of the investigator may prevent the patient complete the study; -hours of stroke onset unknown (in stroke upon awakening is taken as the start time of the last time the patient was seen asymptomatic); -contraindication to standard procedure of peritoneal dialysis, -haemorrhagic stroke in the imaging scan performed at baseline, -stroke or myocardial infarction within the previous 90days, -platelet count 1.3 times the control group, -participation in another clinical trial within the previous 90 days.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): SAFETY AND VIABILITY;Timepoint(s) of evaluation of this end point: CLINICAL PRESENCE OF SIDE EFFECTS (HYPOTENSION, CARDIOVASCULAR AND HEMODYNAMIC, DIGESTIVE, ABDOMINAL-SPECIAL WATCH OR INCIDENTS OF BLEEDING-VISCERA PERFORATION, INFECTION, NEUROLOGICAL DETERIORATION DUE TO INTRACRANIAL HYPERTENSION OR HEMORRHAGIC TRANSFORMATION. ANALYTICAL CONTROLS OF HEMATOCRIT, HEMOGLOBIN, LEUKOCYTES, ESR, PLATELETS, FIBRINOGEN, T.QUICK, APTT, ION, BLOOD GLUCOSE, LIVER FUNCTION AND RENAL FUNCTION AT BASELINE AND 24 AND 72H AND 7 DAYS. VOLUME OF HYPODENSITY, HEMORRHAGIC TRANSFORMATION ON CT 24H AND 72H, EARLY NEUROLOGICAL DETERIORATION (INCREASE OF 4 OR MORE POINTS IN THE NIHSS SCALE FOR THE FIRST 24H) AND MORTALITY TO 3 MONTHS. MEDICAL COMPLICATIONS AND SERIOUS ADVERSE EVENTS;Main Objective: To establish the viability and safety of this clinical-stage study in patients with cerebral infarction who underwent a peritoneal dialysis procedure in the acute phase (a conventional dialysis fluid enriched with phosphate will be used). This study is established as a preliminary step for a more extensive clinical trial that has as main objective efficacy parameters.;Secondary Objective: To determine the potential efficacy and clinical benefit as estimated by infarct volume, mortality and functional status of patients at 90 days by applying mRS scale. To research the evolution of Glu levels in serum and peritoneal dialysis in patients with cerebral infarction in the acute phase.	—

Measure

Time frame

Primary end point(s): SAFETY AND VIABILITY;Timepoint(s) of evaluation of this end point: CLINICAL PRESENCE OF SIDE EFFECTS (HYPOTENSION, CARDIOVASCULAR AND HEMODYNAMIC, DIGESTIVE, ABDOMINAL-SPECIAL WATCH OR INCIDENTS OF BLEEDING-VISCERA PERFORATION, INFECTION, NEUROLOGICAL DETERIORATION DUE TO INTRACRANIAL HYPERTENSION OR HEMORRHAGIC TRANSFORMATION. ANALYTICAL CONTROLS OF HEMATOCRIT, HEMOGLOBIN, LEUKOCYTES, ESR, PLATELETS, FIBRINOGEN, T.QUICK, APTT, ION, BLOOD GLUCOSE, LIVER FUNCTION AND RENAL FUNCTION AT BASELINE AND 24 AND 72H AND 7 DAYS. VOLUME OF HYPODENSITY, HEMORRHAGIC TRANSFORMATION ON CT 24H AND 72H, EARLY NEUROLOGICAL DETERIORATION (INCREASE OF 4 OR MORE POINTS IN THE NIHSS SCALE FOR THE FIRST 24H) AND MORTALITY TO 3 MONTHS. MEDICAL COMPLICATIONS AND SERIOUS ADVERSE EVENTS;Main Objective: To establish the viability and safety of this clinical-stage study in patients with cerebral infarction who underwent a peritoneal dialysis procedure in the acute phase (a conventional dialysis fluid enriched with phosphate will be used). This study is established as a preliminary step for a more extensive clinical trial that has as main objective efficacy parameters.;Secondary Objective: To determine the potential efficacy and clinical benefit as estimated by infarct volume, mortality and functional status of patients at 90 days by applying mRS scale. To research the evolution of Glu levels in serum and peritoneal dialysis in patients with cerebral infarction in the acute phase.

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: THE POTENTIAL EFFICACY AND CLINICAL BENEFIT WILL BE ESTIMATED A) QUANTIFYING THE VOLUME OF INFARCTED TISSUE (CONSIDER A REDUCTION IN INFARCTED TISSUE 20% VS CONTROL) AND B) NEUROLOGICAL STATUS-A FAVORABLE OUTCOME IN NEUROLOGICAL DEFICIT (NIHSS 0.1 OR IMPROVEMENT ? 10 POINTS) AND FUNCTIONAL STATUS (MODIFIED RANKIN SCALE (MRS) ? 2, ASSESSED WITH STRUCTURED INTERVIEW) TO 7 DAYS, OR AT THE TIME OF HIGH IF BEFORE, AND 3 MONTHS. DETERMINATION OF THE CONCENTRATION OF GLUTAMATE IN THE SERUM AND LIQUID DIALYSATE OF PATIENTS AND THEIR CORRELATION WITH INFARCT SIZE AND NEUROLOGICAL DEFICITS.;Secondary end point(s): efficacy (potential efficacy and clinical benefit)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: THE POTENTIAL EFFICACY AND CLINICAL BENEFIT WILL BE ESTIMATED A) QUANTIFYING THE VOLUME OF INFARCTED TISSUE (CONSIDER A REDUCTION IN INFARCTED TISSUE 20% VS CONTROL) AND B) NEUROLOGICAL STATUS-A FAVORABLE OUTCOME IN NEUROLOGICAL DEFICIT (NIHSS 0.1 OR IMPROVEMENT ? 10 POINTS) AND FUNCTIONAL STATUS (MODIFIED RANKIN SCALE (MRS) ? 2, ASSESSED WITH STRUCTURED INTERVIEW) TO 7 DAYS, OR AT THE TIME OF HIGH IF BEFORE, AND 3 MONTHS. DETERMINATION OF THE CONCENTRATION OF GLUTAMATE IN THE SERUM AND LIQUID DIALYSATE OF PATIENTS AND THEIR CORRELATION WITH INFARCT SIZE AND NEUROLOGICAL DEFICITS.;Secondary end point(s): efficacy (potential efficacy and clinical benefit)

—

Countries

Spain

Contacts

Public ContactMONICA SOBRADO

FUNDACION INVESTIGACION BIOMEDICA

sobrado.m@med.ucm.es+34915202416

Outcome results

None listed

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