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Effects of Vitamin C Administration on Extravascular Lung Water in Patients With Severe Features of Preeclampsia

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ClinicalTrials.gov Identifier: NCT03451266
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Miha Lucovnik, University Medical Centre Ljubljana

Brief Summary:
The objective of the study is to determine whether administration of vitamin C (1.5g/6 hours) in the first three days post-partum reduces the amount of extravascular lung water assessed by lung ultrasound in patients with severe preeclampsia.

Condition or disease Intervention/treatment Phase
Preeclampsia Severe Preeclampsia Postpartum Drug: Vitamin C Drug: placebo Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Vitamin C Administration on Extravascular Lung Water in Patients With Severe Features of Preeclampsia: a Randomized, Placebo-controlled Trial
Actual Study Start Date : April 7, 2018
Estimated Primary Completion Date : April 7, 2020
Estimated Study Completion Date : April 7, 2020


Arm Intervention/treatment
Experimental: Vitamin C
1,5g of IV vitamin C in 100 ml 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum (vitamin C arm).
Drug: Vitamin C
1,5g of IV vitamin C in 100 ml 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum.

Placebo Comparator: placebo
100 ml of IV 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum (placebo arm).
Drug: placebo
100 ml of IV 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum.




Primary Outcome Measures :
  1. Echo Comet Score at day 1 post-delivery [ Time Frame: Echo Comet Score (ECS) will be assessed by lung ultrasound at day 1 following delivery ]
    The primary outcome studied will be the Echo Comet Score (ECS) at day 1 following delivery in the vitamin C vs. placebo group. ECS will be obtained by the 28-rib interspaces technique dividing the chest wall in 12 areas on the left (from the second to the fourth intercostal space) and 16 areas on the right (from the second to the fifth intercostal space) anterior and lateral hemithorax. The sum of ultrasonographic B-lines found on each scanning site (from 0 to 10) will yield a score ranging from 0 to 280. ECS denotes the amount of extravascular fluid in the lung, i.e. the higher the ESC, the larger the amount of extravascular lung water.


Secondary Outcome Measures :
  1. Echo Comet Score at day 2 post-delivery [ Time Frame: Echo Comet Score (ECS) will be assessed by lung ultrasound at day 2 following delivery ]
    One of the secondary outcomes studied will be the Echo Comet Score (ECS) at day 2 following delivery in the vitamin C vs. placebo group. ECS will be obtained by the 28-rib interspaces technique dividing the chest wall in 12 areas on the left (from the second to the fourth intercostal space) and 16 areas on the right (from the second to the fifth intercostal space) anterior and lateral hemithorax. The sum of ultrasonographic B-lines found on each scanning site (from 0 to 10) will yield a score ranging from 0 to 280. ECS denotes the amount of extravascular fluid in the lung, i.e. the higher the ESC, the larger the amount of extravascular lung water.

  2. Echo Comet Score at day 3 post-delivery [ Time Frame: Echo Comet Score (ECS) will be assessed by lung ultrasound at day 3 following delivery ]
    One of the secondary outcomes studied will be the Echo Comet Score (ECS) at day 3 following delivery in the vitamin C vs. placebo group. ECS will be obtained by the 28-rib interspaces technique dividing the chest wall in 12 areas on the left (from the second to the fourth intercostal space) and 16 areas on the right (from the second to the fifth intercostal space) anterior and lateral hemithorax. The sum of ultrasonographic B-lines found on each scanning site (from 0 to 10) will yield a score ranging from 0 to 280. ECS denotes the amount of extravascular fluid in the lung, i.e. the higher the ESC, the larger the amount of extravascular lung water.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Singleton pregnancy with severe featutes of preeclampsia (any of the following):

  • Systolic blood pressure of 160 mm Hg or higher, or diastolic blood pressure of 110 mm Hg or higher on two occasions at least 4 hours apart while the patient is on bed rest (unless antihypertensive therapy is initiated before this time)
  • Thrombocytopenia (platelet count less than 100x109/L)
  • Impaired liver function as indicated by abnormally elevated blood concentrations of liver enzymes (to twice normal concentration), severe persistent right upper quadrant or epigastric pain unresponsive to medication and not accounted for by alternative diagnoses, or both
  • Progressive renal insufficiency (serum creatinine concentration greater 97 µmol/L or a doubling of the serum creatinine concentration in the absence of other renal disease)
  • Pulmonary edema
  • New-onset cerebral or visual disturbances

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451266


Contacts
Contact: Miha Lucovnik, MD, PhD 031318681 ext +386 miha.lucovnik@kclj.si

Locations
Slovenia
UMC Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Miha Lucovnik, PhD, MD    +38631318681    miha.lucovnik@kclj.si   
Sponsors and Collaborators
University Medical Centre Ljubljana
  Study Documents (Full-Text)

Documents provided by Miha Lucovnik, University Medical Centre Ljubljana:

Publications:
Responsible Party: Miha Lucovnik, Principal Investigator, Head of the Perinatal Intensive Medicine Unit, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03451266     History of Changes
Other Study ID Numbers: 2017 0031
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Miha Lucovnik, University Medical Centre Ljubljana:
preeclampsia
vitamin C
lung ultrasound

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents