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

NCT ID: NCT03529097

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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?

Conditions

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Renal Colic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

0.9% Sodium-chloride

Intervention Type DRUG

2 liters of 0.9% NaCl IV fluids

Optalgin, Voltaren, Morphine

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type 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

Optalgin, Voltaren, Morphine

Intervention Type DRUG

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

Interventions

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0.9% Sodium-chloride

2 liters of 0.9% NaCl IV fluids

Intervention Type 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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SHEBA-18-4262-NK-CTIL

Identifier Type: -

Identifier Source: org_study_id

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