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

NCT03529097 | Withdrawn Phase 4 DMC

• 1 other identifier: SHEBA-18-4262-NK-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Renal Colic

Outcome Measures

Primary Outcomes (3)

• 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)

  1 month

• 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)

  0 to 1 month

• 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

  6 hours

Secondary Outcomes (2)

• Pain

  1 Hour

• Pain

  1 month

Study Arms (2)

Fluids

ACTIVE COMPARATOR

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; Drug: Optalgin, Voltaren, Morphine

Placebo

PLACEBO COMPARATOR

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; Drug: Optalgin, Voltaren, Morphine

Interventions

0.9% Sodium-chloride DRUG

2 liters of 0.9% NaCl IV fluids

Fluids

Placebos DRUG

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

Placebo

Optalgin, Voltaren, Morphine DRUG

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

Fluids; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead

MeSH Terms

Conditions

Renal Colic

Interventions

Sodium Chloride; Dipyrone; Diclofenac; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 18, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 4, 2021

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share