Kidney Injury Biomarkers in Preeclampsia

Hypertension, Pregnancy-Induced Clinical Trial

Official title:

Evaluation of Kidney Injury Biomarkers in Women Suffering From Preeclampsia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03217916
• Other study ID #: gemy
• Status: Not yet recruiting
• Phase: N/A
• First received: July 11, 2017
• Last updated: July 13, 2017
• Start date: August 1, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: July 2017
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

we found different pattern of podocyte glycoproteins and kidney injury biomarkers in urine specimens between preeclampsia and pregnancy complicated with chronic hypertention compared with normotensive pregnant controls.abnormally elevayed urine biomarkers in severe preeclampsia were completely or prtially reduced 6-8 weaks after delivery to levels comparable with those of normal pregnant subjects.

Description:

Study design:

• Type of the study: Aprospective cross sectional study .All patients will be enrolled in the study after obtaining a written consent.

• Setting: This study will be carried in the Emergency room of Assiut university Hospital &Luxor International Hospital

Statistical Methods:

Inclusion criteria:

• the presence of informed consent

• Prim gravid or multi gravid <5

• age:18-35 ys

• Singleton pregnancy with gestational age >34weeks.

Exclusion criteria:

• Serious maternal illness.

• Smokers

• women with pregnancy complicated by nephritic syndrome, diabetic mellitus, or gestational diabetes

• women known to have renal disease

• oliguria

• Methods :

200 patients with severe peclampsia will be recorded in Assiut university hospital and luxor international hospital in aperiod of 6 months initial assessement: Blood pressure will be measuerd in ER urine analysis will be done in ER by Urine Dipstick Analysis 40 cases will be randomized selected where urine sample will be collected to analyze the markers to be studied

The women will be subjected to the following:

1. Detailed history taking

2. Clinical examination:

1. General examination: pulse, temperature, blood pressure, body weight and height, body mass index.

2. Abdominal examination.

3. obestetric Ultrasonography to calculate gestational age,viability , amniotic fluid ,placental site and to exclude any congenital malformation.

4. Assessemet of renal function :urine output,blood urea,serum creatinine, u/s

5. All routine investigations: C.B.C., Rh, blood grouping, kidney functions tests, liver enzymes.

6. sample collection : Freshly obtained urine specimens were centrifuged at 1,500 rpm for 10 min within 30 min of collection, aliquoted, and stored at _70°C until assayed. Dipstick detection for urine protein, pH, and gravity. Urine protein, pH, gravity, etc. were detected by Dipstick (Uri-Trak-3) in all urine specimens before being aliquoted for storage at _70°C. Urine protein was positive for all study subjects in mild and severe preeclamptic groups.

Biomarkers evaluated in urine specimens including podocyte glycoproteins nephrin and podocalyxin, All biomarkers were measured by ELISA. Assay information for sources of ELISA kits, standard cure range, sample dilution factors, etc.

All assays will be performed following the manufacture's instructions. All specimens will be measured in duplicate.

Personnel who performed the assays of analyteswere blinded to the clinical information.

6. postnatal visits: Postnatal investigation, monitoring and treatment (including after discharge from critical care) Blood pressure

Weekly till the end of puerperium.the postatal visits will iclude:

• Measurement of blood pressure

• U/S kidney

• Askig about urinary symptoms as amout of urine ,colour of urine ,and burning sensation.

Postnatal care will be done according to NICE clinical guidelines at the nearby patients health care centre .the patients will be handed on information sheet containing instructions about postnatal care. the patients will be followed up by telephone to report any abnormalities that may occur

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• the presence of informed consent

• Prim gravid or multi gravid <5

• age:18-35 ys

• Singleton pregnancy with gestational age >34weeks

Exclusion Criteria:

• Serious maternal illness.

• Smokers

• women with pregnancy complicated by nephritic syndrome, diabetic mellitus, or gestational diabetes

• women known to have renal disease

• oliguria

Related Conditions & MeSH terms

• Hypertension, Pregnancy-Induced
• Pre-Eclampsia

Intervention

Diagnostic Test:
• Elisa assay of podocyte glycoprotein in urine
Biomarkers evaluated in urine specimens including podocyte glycoproteins nephrin and podocalyxin, All biomarkers were measured by ELISA. Assay information for sources of ELISA kits, standard cure range, sample dilution factors, etc. All assays will be performed following the manufacture's instructions. All specimens will be measured in duplicate. Personnel who performed the assays of analyteswere blinded to the clinical information.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt	Luxor International Hospital

References & Publications (3)

Karumanchi SA, Lindheimer MD. Preeclampsia and the kidney: footprints in the urine. Am J Obstet Gynecol. 2007 Apr;196(4):287-8. — View Citation

Sibai B, Dekker G, Kupferminc M. Pre-eclampsia. Lancet. 2005 Feb 26-Mar 4;365(9461):785-99. Review. — View Citation

Wang Y, Gu Y, Loyd S, Jia X, Groome LJ. Increased urinary levels of podocyte glycoproteins, matrix metallopeptidases, inflammatory cytokines, and kidney injury biomarkers in women with preeclampsia. Am J Physiol Renal Physiol. 2015 Dec 15;309(12):F1009-17. doi: 10.1152/ajprenal.00257.2015. Epub 2015 Oct 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnitude of renal injury caused by preclampsia	the changes in renal chemistry (serum creatinine and blood urea) in pregnant women with severe preclampsia	within 6 month postpartum
Secondary	Apgar score of the deliverd fetus	standard score to assess fetal status after delivery	1, 5 and 10 minutes after delivery