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

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: NCT03529097
Recruitment Status : Unknown
Verified April 2018 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 18, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:
A randomised controlled trial to evaluate the role of IV fluids in renal colic.

Condition or disease Intervention/treatment Phase
Renal Colic Drug: 0.9% Sodium-chloride Drug: Placebos Drug: Optalgin, Voltaren, Morphine Phase 4

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 -

  1. 2 liters of 0.9% NACL IV fluids with pain killers
  2. 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?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate the Efficiency of IV Fluids in the Treatment of Renal Colic
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Active Comparator: Fluids
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
Drug: 0.9% Sodium-chloride
2 liters of 0.9% NaCl IV fluids

Drug: Optalgin, Voltaren, Morphine
Oral and IV Optalgin, Voltaren IM (intramuscular), Morphine IV. All according to the pain intensity and with concordance to the physician.

Placebo Comparator: Placebo
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
Drug: Placebos
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

Drug: Optalgin, Voltaren, Morphine
Oral and IV Optalgin, Voltaren IM (intramuscular), Morphine IV. All according to the pain intensity and with concordance to the physician.




Primary Outcome Measures :
  1. Stone ejection without intervention [ Time Frame: 1 month ]
    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)

  2. The need for urological intervention [ Time Frame: 0 to 1 month ]
    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)

  3. Pain [ Time Frame: 6 hours ]
    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 :
  1. Pain [ Time Frame: 1 Hour ]
    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

  2. Pain [ Time Frame: 1 month ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.)

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): NCT03529097


Contacts
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Contact: Tomer Drori, MD 0547910408 tomerdrori1@gmail.com
Contact: Nir Kleinman, MD 0533398845

Sponsors and Collaborators
Sheba Medical Center
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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03529097    
Other Study ID Numbers: SHEBA-18-4262-NK-CTIL
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Colic
Renal Colic
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Dipyrone
Diclofenac
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics