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

Sponsor

Sheba Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03529097

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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 -

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?

Study Design

Study Type:

Interventional

Actual Enrollment :

0 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

Anticipated Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Stone ejection without intervention [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)
The need for urological intervention [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)
Pain [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

Pain [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
Pain [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT03529097

Other Study ID Numbers:

SHEBA-18-4262-NK-CTIL

First Posted:

May 18, 2018

Last Update Posted:

Oct 4, 2021

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2021