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Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache (PROPHYDRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02859233
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

Postdural puncture headache (PDPH) is defined, according to the International Headache Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying.

For preventing PDPH, there are some uncomfortable practices for patients (fluid supplementation and bed rest) and expensive for hospital (time spend for information and management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not effective in prevention of PDPH, "fluid supplementation" is not an advice based on any evidence but only on routine. By this trial, the investigators want to evaluate the scientific value of this advice, in the standard patient care.

The primary objective of this study is to compare oral hyperhydration (2 liters during 2 hours after lumbar puncture - the most common routine according to an internal pilot survey) versus no advice about the fluid intake to prevent the PDPH.

The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.


Condition or disease Intervention/treatment Phase
Postdural Puncture Headache Other: Lack of hyperhydration Not Applicable

Detailed Description:

Postdural puncture headache (PDPH) is defined, according to the International Headache Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying.

For preventing PDPH, there are some uncomfortable practices for patients (fluid supplementation and bed rest) and expensive for hospital (time spend for information and management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not effective in prevention of PDPH, "fluid supplementation" is not an advice based on any evidence but only on routine. By this trial, the investigators want to evaluate the scientific value of this advice by non-inferiority study, in the standard patient care.

The primary objective of this study is to compare oral hyperhydration (2 liters during 2 hours after lumbar puncture - the most common routine according to an internal pilot survey) versus no advice about the fluid intake to prevent the PDPH. It will be evaluated on the occurrence of PDPH in both of the two groups The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 554 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache: A Non-inferiority Randomized Controlled Trial
Actual Study Start Date : November 8, 2016
Actual Primary Completion Date : July 23, 2019
Actual Study Completion Date : July 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
No Intervention: Control group
Routine advices about the interest of increase fluid after lumbar puncture to prevent PDPH will be transmitted: 2 liters will be provided to be drunk in 2 hours.
Experimental: Interventional group
Lack of hyperhydration : no particular advices will be transmitted about the interest of oral hyperhydration. 500 milliliters will be provided in case of thirst, according to patient's convenience.
Other: Lack of hyperhydration



Primary Outcome Measures :
  1. The incidence of PDPH. [ Time Frame: At D5 ]
    PDPH will be observed on the 5th day (D5) after the lumbar puncture (D0). If PDPH is still present on the 5th day, the patient continues to be followed until the 8th day after the lumbar puncture

  2. The incidence of PDPH (in case of PDPH still present at D5). [ Time Frame: At D8 ]
    PDPH will be observed also on the 8th day (D8) after the lumbar puncture (D0). , if PDPH was still present on the 5th day, to confirm the diagnosis of PDPH.


Secondary Outcome Measures :
  1. The date of apparition of PDPH between day 0 and day 5 [ Time Frame: between day 0 and day 5 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient in need of dural puncture for diagnostic.
  • Age between 18 and 60 years old.
  • Patient willing to participate in the research.

Exclusion Criteria:

  • Pregnancy.
  • Contraindication for increased oral fluid intake.
  • Previous dural puncture within 5 day prior enrollment.
  • Parenteral fluid intake superior at 266 ml for 2 hours after dural puncture (1000 ml per day).
  • Enteral artificial feeding.
  • Patient not in capacity to understand correctly French.
  • Patient whose cannot be followed correctly by phone.
  • Patient refusing to participate in the study.

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): NCT02859233


Locations
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France
Hospital centre CHD VENDEE
La Roche Sur Yon, France, 85925
Hospital centre LE MANS
Le Mans, France, 72037
University Hospital NANTES
Nantes, France, 44093
Hospital centre CORNOUAILLE
Quimper, France, 29107
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Emmanuelle CARTRON Nantes University Hospital

Publications:
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02859233    
Other Study ID Numbers: RC16_0031
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nantes University Hospital:
Spinal Puncture
Dural puncture
Nursing
Additional relevant MeSH terms:
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Post-Dural Puncture Headache
Headache
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases