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Preeclampsia SeverePhase 1NCT03451266

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

A Phase 1 study testing Vitamin C in people with Preeclampsia Severe and Preeclampsia Postpartum, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Preeclampsia Severe, Preeclampsia Postpartum
What is being tested?
Vitamin C
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteSlovenia
Study dates
7 Apr 2018to 27 Jun 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Slovenia1 site
  • UMC Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: Effects of Vitamin C Administration on Extravascular Lung Water in Patients With Severe Features of Preeclampsia: a Randomized, Placebo-controlled Trial

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.

Read the detailed description

Risk of fluid over-resuscitation is high in preeclampsia due to endothelial dysfunction and resulting increased vascular permeability. The Confidential Enquiry into Maternal Deaths in the UK reported six maternal deaths between 1994 and 1996 due to adult respiratory distress syndrome (ARDS) that appeared to be related to poor fluid management in women with preeclampsia. On the basis of these reported deaths, recommendations on limiting intravenous fluids to not more than to 80 ml/hour (or 1 ml/kg/h) have been made. Nevertheless, preeclampsia remains the leading cause of pulmonary edema in the peripartum period. Moreover, in some preeclamptic patients higher rates of intravenous fluid administration may be necessary to adequately correct tissue hypoperfusion.

Zieleskiewicz et al. were the first to demonstrate that lung ultrasound (LUS) can be used to objectively evaluate increased extravascular lung water (EVLW) in patients with preeclampsia. Ambrozic et al. recently confirmed these results and showed that the amount of EVLW assessed by LUS is increased in preeclamptic patients compared to healthy controls and that it decreases rapidly in the first four days following delivery.

It has been reported that administration of high-dose ascorbic acid (vitamin C) reduces vascular permeability in animals. In 2000, Tanaka et al. reported an RCT involving 37 patients with major burns (>30% body surface area) randomized regarding whether or not to receive an infusion of IV vitamin C, 66 mg/kg/h for the first 24 hours of hospitalization. Patients in the vitamin C group required less fluid resuscitation, had higher urine output, and developed less wound edema. This translated into improved oxygenation and less time on mechanical ventilation among the vitamin C group (average of 12 vs. 21 days of ventilation, p=0.03). In 2002, Nathens et al. randomized patients shortly after admission to a surgical ICU to no therapy vs. a combination of enteral vitamin E plus IV vitamin C 1000 mg/8h until ICU discharge. The primary endpoint was a composite of pneumonia or ARDS. Although there were trends towards fewer pulmonary complications among patients treated with antioxidants, these did not reach statistical significance (the study was underpowered due to low rates of respiratory complications). However, patients treated with vitamins E and C fared better on a variety of secondary endpoints including less time on the ventilator and less multiorgan failure.

In women with established preeclampsia, there is evidence of oxidative stress and decreased concentrations of vitamin C. An initial RCT on prophylactic supplementation with oral antioxidants, including 1g vitamin C daily, showed a significant reduction in preeclampsia (8 percent vs. 17 percent) in high-risk pregnancies. Subsequent large RCTs have, however, reported no significant reduction in the risks of preeclampsia, intrauterine growth restriction, or the risk of death or other serious outcomes in infants associated with oral vitamin C supplementation.There are no studies to date on use of higher dose IV vitamin C administration for reduction of capillary leak and consequently EVLW in patients with severe forms of preeclampsia. Given the safety (see below) and low costs of vitamin C this could be a promising approach to increase fluid tolerance in these patients. If vitamin C reduces vascular permeability in preeclampsia patients to the same degree that it seems to reduce vascular permeability in other conditions, such as burns, it could reduce the risk of pulmonary complications associated with this disease. At the same time, vitamin C therapy could allow safe additional fluid administration in patients with preeclampsia who are fluid responsive and in whom further increases in preload would be beneficial for preventing end-organ damage such as pre-renal acute kidney injury.

Safety of vitamin C

Safety of vitamin C has been well established even at high doses. For example, none of the above studies reported any adverse event, despite the use of very high doses by Tanaka et al. (1.6 grams/kg over 24 hours). One potential concern regarding vitamin C is that it may be metabolized into oxalic acid, leading to calcium oxalate nephropathy. This doesn't seem to be a significant problem for several reasons:

  • Oxalate formation is a dose-dependent toxicity. This has rarely been reported from short courses of IV vitamin C, but only at much higher doses (>40 grams/day).
  • In 2014, Fowler et al. published a phase I safety trial of vitamin C in patients with severe sepsis. Their prospective RCT involved patients with severe sepsis in a medical ICU. 24 patients were randomized to receive placebo, low-dose vitamin C (12.5 mg/kg IV/6hr), or high-dose vitamin C (50 mg/kg IV/6hr). The primary endpoint was safety and tolerability, with no adverse events noted.
  • Recently Marik et al. published a before-after study investigating the impact of treating sepsis with a combination of thiamine 200 mg IV/12hr, Vitamin C 1.5 g/6hr, and hydrocortisone 50 mg IV/6hr. Mortality was substantially reduced in patients receiving vitamin C (p<0.001). Moreover, vitamin C use correlated with improved renal outcomes (the rate of dialysis was reduced from 33% to 10%, p=0.02).

Another concern which has been raised is that vitamin C at extremely high doses may have a pro-oxidant effect. This was shown not to occur even at a dose of 7.5 grams IV daily.

Being tested
Vitamin C, placebo
Keywords
preeclampsia, vitamin C, lung ultrasound
Medical subject headings
Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin CDrug

    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.

  • placeboDrug

    100 ml of IV 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum.

Study groups in NCT03451266
Study groupRoleWhat they receive
Vitamin CExperimental1,5g 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).
Receives: Drug: Vitamin C
placeboPlacebo comparator100 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).
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Echo Comet Score at day 1 post-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.

    Measured: Echo Comet Score (ECS) will be assessed by lung ultrasound at day 1 following delivery

Secondary outcomes (2)
  1. Echo Comet Score at day 2 post-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.

    Measured: Echo Comet Score (ECS) will be assessed by lung ultrasound at day 2 following delivery

  2. Echo Comet Score at day 3 post-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.

    Measured: Echo Comet Score (ECS) will be assessed by lung ultrasound at day 3 following delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2018
  2. Study start7 Apr 2018
  3. Primary completion25 Jun 2019
  4. Study completion27 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03451266
Sponsor's protocol ID
2017 0031
Status last verified
Jun 2019
First submitted
17 Feb 2018
Last updated
28 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zieleskiewicz L, Contargyris C, Brun C, Touret M, Vellin A, Antonini F, Muller L, Bretelle F, Martin C, Leone M. Lung ultrasound predicts interstitial syndrome and hemodynamic profile in parturients with severe preeclampsia. Anesthesiology. 2014 Apr;120(4):906-14. doi: 10.1097/ALN.0000000000000102.

    PubMed 24694847
  • Ambrozic J, Brzan Simenc G, Prokselj K, Tul N, Cvijic M, Lucovnik M. Lung and cardiac ultrasound for hemodynamic monitoring of patients with severe pre-eclampsia. Ultrasound Obstet Gynecol. 2017 Jan;49(1):104-109. doi: 10.1002/uog.17331. Epub 2016 Dec 1.

    PubMed 27736042
  • Matsuda T, Tanaka H, Hanumadass M, Gayle R, Yuasa H, Abcarian H, Matsuda H, Reyes H. Effects of high-dose vitamin C administration on postburn microvascular fluid and protein flux. J Burn Care Rehabil. 1992 Sep-Oct;13(5):560-6. doi: 10.1097/00004630-199209000-00009.

    PubMed 1452590
  • Tanaka H, Matsuda T, Miyagantani Y, Yukioka T, Matsuda H, Shimazaki S. Reduction of resuscitation fluid volumes in severely burned patients using ascorbic acid administration: a randomized, prospective study. Arch Surg. 2000 Mar;135(3):326-31. doi: 10.1001/archsurg.135.3.326.

    PubMed 10722036
  • Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J. Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study. Chest. 2017 Jun;151(6):1229-1238. doi: 10.1016/j.chest.2016.11.036. Epub 2016 Dec 6.

    PubMed 27940189
  • Korenc M, Zieleskiewicz L, Stopar Pintaric T, Blajic I, Ambrozic J, Lucovnik M. The effect of vitamin C on pulmonary oedema in patients with severe preeclampsia: A single-centre, randomised, placebo-controlled, double-blind trial. Anaesth Crit Care Pain Med. 2021 Feb;40(1):100800. doi: 10.1016/j.accpm.2021.100800. Epub 2021 Jan 14.

    PubMed 33453456

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vitamin C in people with Preeclampsia Severe and Preeclampsia Postpartum, run by University Medical Centre Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03451266, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.

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