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Evaluation of the Roll of IV Fluids in the Treatment of Renal Colic

Primary Purpose

Renal Colic

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
0.9% Sodium-chloride
Placebos
Optalgin, Voltaren, Morphine
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Colic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • above 18 years
  • clinical renal colic
  • a radiological proof (CT,US) to urolithiasis

Exclusion Criteria:

  • below 18 years
  • has a contraindication for IV fluids (such as CHF (Congestive Heart Failure)etc.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Fluids

    Placebo

    Arm Description

    Intervention: 2 liters of 0.9% NaCl IV during the ER stay with pain killers. For placebo purposes this arm participants will get an infusion with black cover so they could not tell if it drips or not

    No interventions, Only pain killers. For placebo purposes this arm participants will get an infusion with black cover so they could not tell if it drips or not

    Outcomes

    Primary Outcome Measures

    Stone ejection without intervention
    Has the stone ejected without intervention? 1 month after the first visit in the ER (Emergency Room) we will preform an US or CT exam to verified that the stone ejected. If the stone that was seen by the US or CT in the ER is not present after 1 month we will assume it was spontaneously ejected. we would like to find out if there is any differences between the 2 groups in matter of spontaneously stone ejection. (Yes or No)
    The need for urological intervention
    The need for urological intervention. 1 month after the visit in the ER we will check if the patient have gone through urological intervention such as urolithiasis. We would like to find out if there is any difference between the two groups in matter of urological intervention between 1 month after the visit in the ER. (Yes or No)
    Pain
    Measure the VAS (Visual Analogue pain Score). Between 1-10 1 is no pain and 10 in the strongest pain. a scale between 1-10 is shown to the patients and they are asked how they feel after 6 hours of treatment in the ER

    Secondary Outcome Measures

    Pain
    Measure the VAS Between 1-10 1 is no pain and 10 in the strongest pain. a scale between 1-10 is shown to the patients and they are asked how they feel after 1 hour of treatment in the ER
    Pain
    Measure the VAS Between 1-10 1 is no pain and 10 in the strongest pain. a scale between 1-10 is shown to the patients and they are asked how they feel after 1 month from the first visit in the ER

    Full Information

    First Posted
    April 23, 2018
    Last Updated
    September 27, 2021
    Sponsor
    Sheba Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03529097
    Brief Title
    Evaluation of the Roll of IV Fluids in the Treatment of Renal Colic
    Official Title
    Randomized Controlled Trial to Evaluate the Efficiency of IV Fluids in the Treatment of Renal Colic
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No participants enrolles
    Study Start Date
    June 1, 2018 (Anticipated)
    Primary Completion Date
    December 31, 2019 (Anticipated)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sheba Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A randomised controlled trial to evaluate the role of IV fluids in renal colic.
    Detailed Description
    A RCT (Randomized Controlled Trial)to evaluate the role of 0.9% NACL (sodium chloride) IV fluids during an acute renal colic. The 2 arms will include - 2 liters of 0.9% NACL IV fluids with pain killers only pain killers The object is to find out if the IV fluids has any advantage in the care of renal colic. Does it helps to relive the pain? Does the stone eject earlier? Will there be fewer interventions?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Colic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fluids
    Arm Type
    Active Comparator
    Arm Description
    Intervention: 2 liters of 0.9% NaCl IV during the ER stay with pain killers. For placebo purposes this arm participants will get an infusion with black cover so they could not tell if it drips or not
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    No interventions, Only pain killers. For placebo purposes this arm participants will get an infusion with black cover so they could not tell if it drips or not
    Intervention Type
    Drug
    Intervention Name(s)
    0.9% Sodium-chloride
    Intervention Description
    2 liters of 0.9% NaCl IV fluids
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Intervention Description
    2 liters of 0.9% NaCl bag covered with black bag so the participant could not tell the fluids are not dripping to his vain
    Intervention Type
    Drug
    Intervention Name(s)
    Optalgin, Voltaren, Morphine
    Intervention Description
    Oral and IV Optalgin, Voltaren IM (intramuscular), Morphine IV. All according to the pain intensity and with concordance to the physician.
    Primary Outcome Measure Information:
    Title
    Stone ejection without intervention
    Description
    Has the stone ejected without intervention? 1 month after the first visit in the ER (Emergency Room) we will preform an US or CT exam to verified that the stone ejected. If the stone that was seen by the US or CT in the ER is not present after 1 month we will assume it was spontaneously ejected. we would like to find out if there is any differences between the 2 groups in matter of spontaneously stone ejection. (Yes or No)
    Time Frame
    1 month
    Title
    The need for urological intervention
    Description
    The need for urological intervention. 1 month after the visit in the ER we will check if the patient have gone through urological intervention such as urolithiasis. We would like to find out if there is any difference between the two groups in matter of urological intervention between 1 month after the visit in the ER. (Yes or No)
    Time Frame
    0 to 1 month
    Title
    Pain
    Description
    Measure the VAS (Visual Analogue pain Score). Between 1-10 1 is no pain and 10 in the strongest pain. a scale between 1-10 is shown to the patients and they are asked how they feel after 6 hours of treatment in the ER
    Time Frame
    6 hours
    Secondary Outcome Measure Information:
    Title
    Pain
    Description
    Measure the VAS Between 1-10 1 is no pain and 10 in the strongest pain. a scale between 1-10 is shown to the patients and they are asked how they feel after 1 hour of treatment in the ER
    Time Frame
    1 Hour
    Title
    Pain
    Description
    Measure the VAS Between 1-10 1 is no pain and 10 in the strongest pain. a scale between 1-10 is shown to the patients and they are asked how they feel after 1 month from the first visit in the ER
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: above 18 years clinical renal colic a radiological proof (CT,US) to urolithiasis Exclusion Criteria: below 18 years has a contraindication for IV fluids (such as CHF (Congestive Heart Failure)etc.)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Evaluation of the Roll of IV Fluids in the Treatment of Renal Colic

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